Recall of Device Recall BD Biosciences Flow Cytometers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BD Biosciences, Systems & Reagents.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71502
  • Event Risk Class
    Class 3
  • Event Number
    Z-2090-2015
  • Event Initiated Date
    2015-06-15
  • Event Date Posted
    2015-07-16
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Counter, differential cell - Product Code GKZ
  • Reason
    Instruments installed between june 2007 and september 2011 do not contain labeling pursuant to the food and drug administration's (fda's) guidance on laser products- conformance with iec 60825-1 and iec 60601-2-22 (laser notice no. 50).
  • Action
    BD Biosciences sent an Important Product Correction letter dated June 2015 to all affected customers. Customers were informed that a Field Service Engineer will schedule a time to perform the necessary correction. Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt 2). For questions regarding this recall call 408-954-6307.

Device

  • Model / Serial
    Material No. Serial No. 343202 E0565, 343202 E3190, 338960 V96100212, 338962 V96300187, 338962 V96300189, 342975 E97500564, 338962 V96300231, 342975 E97500700, 33300472 H47200110, 338962 V96300567, 338960 V96100817, 338960 V96100911, 338960 V96100913, 338962 V96300761, 338960 V96101255, 648063 H06300007, 647793 H79300005, 343276 E4731, 337175 V07300249, 647785 H64778500001, 647793 H64779300011, 338960 V33896101603, 338962 V33896301405, 340128 W91100061, 340128 W91100104, 343202 E0035, 343202 E0108, 343202 E0692, 343202 E0849, 343202 E3313, 343202 E3355, 343023 E0722, 343023 E1312, 343023 E3108, 654899 V96101131, 340469 P46900047, 644655 00-00059-00, 340551 H47100064, 644655 00-00068-00, 340469 P46900070, 341360 P22300058, 342975 E97500699, 340469 P46900093, 644655 00-00065-00, 643695 P69500019, 340551 H47100133, 643178 P17800016, 643695 P69500029, 643695 P69500031, 338960 V96100758, 340551 H47100171, 340551 H47100180, 340551 H47100193, 340551 H47100197, 643182 P18200019, 341360 P0324, 644655 00-00027-00, 643695 P69500082, 643695 P69500093, 338960 V96101018, 334079 P1003, 644655 Z65500010, 340551 H55100016, 650036 P03600001, 646500 X5000040, 649225 H5B400031, 650109 P10900001, 338960 V33896101581, 647177 H64717700006, 343020 E1774, 343202 E2583, 343268 SE0060, 644655 00-00023-00, 654899 V96100174, 340469 P46900074, 343276 E0511, 340469 P46900092, 340469 P46900091, 340551 H47100089, 338960 V96100546, 338960 V96100172, 342975 E97501071, 340551 H47100177, 643695 P69500103, 643695 P69500104, 340551 H47100229, 340551 H47100234, 647800 H80000006, 338962 V96301224, 643695 P69500081, 343020 E0337, 342975 E97500077, 342975 E97500509, 342975 E97500510, 342975 E97501195, 33717508 V0013, 337175 V07300219, 338962 V96301195, 333999 P99900028, 342975 E97500606, 338960 V96100320, 342973 E97300244, 342975 E97501014, 450500 D08932049, 342976 E97600314, 641548 V96100195, 340551 H47100030, 340551 H47100066, 340551 H47100111, 340551 H47100113, 338960 V96100602, 338960 V96100613, 340551 H47100143, 342975 E97501009, 340128 W91100272, 340551 H47100198, 338960 V96100852, 338960 V96100855, 340551 H47100205, 647177 H17700010, 647785 H78500003, 649225 H5B400009, 340551 H55100027, 649225 H5B400011, 649225 H5B400027, 340128 W91100317, 647800 H80000015, 338962 V33896301359, 343020 E0249, 343202 E5801, 338960 V33896100001, 343073 D0311, 343073 D0644, 342975 E97500467, 342975 E97500618, 342975 E97500994, 342975 E97501260, 342975 E97501126, 338962 V33896301379, 343020 E1262, 343202 E0637, 34320208 E0956, 343202 E0983, 343202 E1124, 343202 E1310, 343023 E0131, 343023 E0678, 340128 W91100290, 33947308 V87500121, 343020 E0329, 343020 E0786, 343202 E0051, 343202 E0178, 343202 E0326, 338960 V96100250, 338962 V96300191, 338960 V96100443, 643695 P69500020, 339473 V87500062, 34297508 E97501010, 339473 V87500066, 338962 V96300519, 338962 V96300649, 338962 V96300719, 338960 V96101104, 338960 V96101111, 643554 V96101177, 338960 V96101406, 338962 V96301189, 338962 V96301190, 338960 V96101491, 338962 V96301268, 343260 E97300268, 342975 E97500506, 340551 H47100047, 343276 E3420, 33407808 P07800142, 33300472 H47200088, 338960 V96100396, 338960 V96100423, 338960 V96100680, 340551 H47100151, 643695 P69500042, 643181 P18100021, 338960 V96100750, 338962 V96300716, 338960 V96101044, 643554 V96300790, 647794 H79400009, 343276 E4421, 645054 P0072, 643178 P17800075, 342975 E97501624, 649225 H5B400034, 334225 PILOT017, 340128 W91100128, 343020 E0023, 343020 E3600, 343202 E0575, 343202 E1167, 343202 E1251, 343202 E2635, 343202 E3052, 338960 V96100616, 33896008 V96100617, 343276 E0049, 644655 00-00071-00, 644655 00-00075-00, 644655 00-00086-00, 644655 00-00082-00, 644655 00-00026-00, 644655 Z65500006, 646500 X5000028, 646500 X5000034, 646500 X5000035, 646500 X5000039, 646500 X5000043, 646500 X5000044, 646500 X5000045, 646500 X64650000047, 343202 E0107, 343202 E0799, 343202 E0838, 343202 E1126, 343202 E1223, 343202 E1264, 343202 E1293, 343202 E1377, 34302308 E1120, 343023 E1133, 338962 V96300178, 342976 E97600122, 342975 E97500614, 338962 V96300294, 342973 E97300193, 343277 E0532, 342975 E97500821, 342975 E97500928, 342975 E97501147, 342975 E97501148, 338962 V96300693, 343276 E97501574, 342975 E97501584, 342975 E97501589, 338962 V96301263, 338962 V96301264, 338962 V33896301355, 338962 V33896301377, 343020 E1109, 343020 E3025, 343022 E0018, 34320208 E0059, 343020 E0330, 34320208 E0907, 342975 E97500513, 34297508 E97500592, 342975 E97500701, 342975 E97500710, 342975 E97501023, 342975 E97501037, 342975 E97501086, 343023 E0140, 338960 V96100216, 338962 V96301027, 338962 V96300203, 34012809 PILOT012, 340469 P46900052, 340128 W91100224, 343276 E1316, 338960 V96100530, 338960 V96100646, 643695 P69500048, 340551 H47100187, 340551 H47100196, 338960 V96101216, 338962 V96301246, 648282 P28200193, 338960 V33896101594, 343020 E0455, 343202 E0218, 343202 E0364, 344860 W91100170, 340469 P46900068, 338960 V96100343, 340551 H47100081, 338960 V96100496, 340469 P46900100, 338960 V96100642, 338960 V96100669, 338960 V96100634, 344860 W91100263, 338960 V96100741, 338960 V96100667, 340551 H47100162, 338960 V96100688, 643695 P69500060, 339473 V87500075, 338962 V96301007, 338962 V96301008, 645054 P0038, 338962 V96300795, 643695 P69500151, 650110 P11000003, 650110 P11000009, 338960 V96101508, 645054 P28200099, 343202 E1069, 338962 V96301162, 34307308 D0513, 340551 H47100080, 340469 P46900095, 340551 H47100095, 340551 H47100122, 340551 H47100121, 342975 E97501007, 340551 H47100170, 643178 P17800024, 340551 H47100183, 33300482 H48200062, 643695 P69500062, 647793 H79300001, 340551 H55100002, 648068 H06800002, 342976 E97600294, 648064 H06400001, 643181 P18100049, 340551 H55100009, 643695 P69500129, 650110 P11000006, 342973 E97300459, 340551 H55100035, 648282 P64828200001, 343020 E0567, 343022 E0685, 343202 E0794, 343023 E1237, 343023 E1252, 343202 E1330, 343020 E0210, 343022 E0919, 343202 E0277, 343202 E0366, 343202 E0406, 343202 E0684, 34297508 E5871, 343276 E97500706, 343023 E0273, 343023 E0305, 64465508 Z65500007, 646500 X5000001, 648282 P28200018, 648282 P28200017, 645054 P69500140, 646500 X5000002, 646500 X5000030, 646500 X5000033, 644655 Z65500002, 644655 Z65500003, 644655 Z65500009, 338960 V96100185, 340551 H47100038, 338962 V96300264, 342975 E97501003, 338960 V96100745, 338962 V96300560, 33300476 H47600118, 33896008 V96100815, 340551 H47100237, 33300482 H48200071, 338962 V96300809, 338962 V96300810, 338960 V96101164, 643554 V96101250, 338960 V96101490, 338960 V33896101609, 343202 E0784, 343202 E1456, 340551 H47100065, 645054 P46900096, 340469 P46900102, 338962 V96300420, 643695 P69500016, 643695 P69500018, 643177 P17700014, 643178 P17800021, 643695 P69500043, 643695 P69500085, 643177 P17700042, 340551 H55100006, 643695 P69500119, 647177 H17700016, 648282 P28200049, 647800 H80000008, 650034 P03400001, 650110 P11000010, 647177 H17700009, 342973 E97300491, 647785 H64778500002, 343202 E0810, 343023 E0054, 343023 E0949, 339101 H0080, 338960 V96100246, 340469 P46900066, 338960 V96100329, 340469 P46900069, 338962 V96300297, 341360 P07900069, 643177 P17700004, 339473 V87500060, 643181 P18100043, 338960 V96100983, 643178 P17800054, 643695 P69500114, 343276 E3045, 643695 P69500148, 643695 P69500150, 650052 P05200001, 648282 P28200142, 338962 V96301247, 648282 P28200188, 643695 P69500158, 334079 P07900013, 650110 P65011000032, 343020 E1326, 343202 E0257, 343202 E1318, 33300478 H47800076, 342975 E97500776, 338960 V96100545, 342975 E97500938, 33300472 H47200112, 342973 E97300398, 342975 E97501405, 342976 E97600317.338960 V96101488, 338962 V33896301357, 343202 E0251, 343202 E1311, 34320208 E3175, 343202 E3976, 343023 E0203, 338960 V96100598, 338960 V96100705, 338962 V96300898, 338962 V96300030, 338960 V96101392, 343202 E1027, 34320208 E5800, 343023 E1315, 343023 E5609, 338962 V96300173, 338962 V96300210, 338962 V96300217, 338960 V96100288, 343276 E2509, 342973 E97300212, 33300476 H47600102, 338960 V96101504, 343020 E0072, 343020 E0840, 343202 E1042, 343023 E0804, 337175 V07300435, 340551 H47100028, 341360 P07900060, 333999 P99900030, 335223 P22300096, 340469 P46900076, 643695 P69500004, 643695 P69500010, 340551 H47100238, 643695 P69500099, 643695 P69500106, 643695 P69500113, 643695 P69500125, 339101 H47100155, 643695 P69500135, 648282 P28200007, 648282 P28200022, 643695 P69500152, 648282 P28200075, 647177 H17700025, 647177 H17700032, 647794 H6477940000024, 340469 P46900042, 340469 P46900045, 338960 V96100359, 340128 W91100225, 340469 P46900090, 338962 V96300367, 643695 P69500002, 338960 V96100624, 643695 P69500047, 643554 V96100899, 338962 V96300728, 647800 H80000001, 338962 V96300820, 338962 V96301057, 339101 H47100022, 643181 P18100060, 338962 V96301194, 647785 H78500004, 338960 V96101497, 338960 V96101524, 643554 V33896101564, 343202 E0233, 34320208 E0371, 343202 E0782, 343023 E0105, 343023 E0199, 338962 V96300221, 338962 V96301109, 340551 H47100036, 338960 V96100291, 33300476 H47600092, 342975 E97500658, 33300482 H48200053, 340128 W91100223, 340551 H47100084, 340551 H47100102, 338960 V96100536, 340128 W91100243, 338960 V96100590, 642324 W91100113, 33300472 H47200108, 340551 H47100201, 340551 H47100210, 340551 H47100206, 340551 H47100208, 338960 V96100882, 343276 E5572, 340128 W91100277, 647177 H17700003, 340551 H55100005, 647177 H17700007, 647177 H17700020, 649225 H5B400003, 338960 V96101325, 338962 V96301213, 647177 H17700033, 649225 H5B400043, 338960 V96101537, 643554 V33896100002, 643554 V33896101563, 34008860 D0050, 343073 D0893, 342975 E97500546, 342975 E97500593, 342975 E97500601, 342975 E97501089, 343202 E0168, 343202 E0480, 343202 E0570, 343202 E20200172, 343202 E2080, 343202 E4394, 343202 E5978, 343023 E0080, 343023 E0577, 338960 V96100243, 343276 E2482, 338962 V96300320, 34326008 E0454, 338960 V96100449, 338960 V96100555, 338960 V96100666, 338962 V96300824, 343022 E0700, 343202 E2711, 34307308 D0940, 342975 E97500557, 343202 E0841, 340469 P46900056, 338960 V96100406, 334078 P07800167, 643181 P18100009, 338960 V96100682, 647794 H79400004, 643695 P69500079, 643695 P69500133, 339101 H10100013, 647177 H17700021, 338962 V96301116, 338962 V96301187, 648282 P28200112, 650034 P03400004, 338962 V96301327, 647794 H79400019, 647794 H79400020, 650110 P65011000026, 650110 P65011000027, 338962 V96300397, 338962 V96300460, 343268 C0167, 342975 E97500665, 342975 E97500823, 343260 E1714, 342976 E97600244, 338960 V96101222, 343276 E3984, 343276 E2825, 343020 E0929, 343202 E0068, 343202 E0069, 34320208 E0097, 343202 E0778, 343202 E0798, 343202 E1169, 343202 E1368, 343202 E1960, 343202 E3198, 34008860 D0254, 645054 P46900039, 338960 V96100286, 338960 V96100344, 340469 P46900081, 33300476 H47600097, 338960 V96100413, 338962 V96300307, 338962 V96300370, 338960 V96100586, 338960 V96100594, 338962 V96300010, 33300472 H47200101, 339101 H47100149, 340551 H47100189, 643695 P69500068, 338960 V96100997, 342975 E97501293, 647785 H78500001, 343276 E5337, 647780 H78000001, 643695 P69500124, 340551 H55100018, 647793 H79300004, 338960 V96101403, 342973 E97300463, 343020 E0240, 343020 E1327, 342975 E97501559, 335860 V07300514, 33896208 V96301102, 335223 P22300094, 340469 P46900061, 340469 P46900063, 340469 P46900067, 334078 P07800155, 340469 P46900073, 340469 P46900080, 334078 P07800161, 334078 P07800163, 335223 P22300095, 643695 P69500012, 643695 P69500083, 643695 P69500116, 648282 P28200090, 648282 P28200105, 648282 P28200138, 338960 V96100244, 340551 H47100059, 338960 V96100402, 338960 V96100436, 338960 V96100467, 338960 V96100397, 338962 V96300364, 338960 V96100609, 340551 H47100123, 342973 E97300270, 338962 V96300435, 343276 E3983, 338960 V96100712, 338962 V96300524, 338960 V96100746, 340551 H47100174, 33300472 H47200104, 338960 V96100686, 338960 V96100792, 338960 V96100794, 338960 V96100954, 647800 H80000002, 338960 V96101135, 338962 V96300107, 342975 E97501497, 338962 V96301165, 649225 H5B300003, 648088 H08800004, 338962 V96301245, 338960 V96101525, 340551 H55100038, 338962 V96301324, 338960 V33896100008, 647794 H6477940000023, 343276 E6190, 334225 W0014, 343020 E0057, 342973 E5519, 343202 E0322, 343020 E0583, 34320208 E1127, 343202 E1161, 343202 E3328, 342976 E97600047, 343023 E1255, 338960 V96100098, 338960 V96100213, 338960 V96100290, 342975 E97500547, 338960 V96100222, 339101 H0137, 338960 V96100254, 342975 E97500584, 33300476 H47600087, 338960 V96100299, 340551 H47100055, 338962 V96300280, 338960 V96100360, 338960 V96100417, 340558 V07300620, 338960 V96100419, 343276 E4129, 343260 E2012, 33300472 H47200095, 342975 E97500894, 338962 V96300423, 340551 H47100137, 342973 E97300281, 338962 V96300453, 338960 V96100756, 338960 V96100725, 338960 V96100727, 342975 E97501092, 342975 E97501093, 338962 V96300613, 643554 V96100881, 338962 V96300679, 340551 H55100014, 343276 E97500097, 649225 H5C300005, 338960 V96101494, 342975 E97501698, 338962 V33896301411, 338962 V33896301425, 343020 E0435, 343202 E0527, 343202 E0744, 343202 E0996, 343202 E4043, 343023 E0017, 343023 E0062, 343023 E1201, 337175 V0067, 338962 V09630014, 338960 V96100394, 338960 V96100414, 338960 V96100507, 338960 V96100539, 338960 V96101553, 338960 V33896100010, 34302008 E1000, 343202 E0627, 343202 E0643, 343202 E0995, 343202 E1257, 343202 E2874, 343023 E0832, 343023 E0860, 343023 E1202, 338962 V96300006, 338960 V96100207, 343276 E0941, 338960 V96101049, 343202 E0369, 343202 E0677, 343023 E1056, 338960 V96100412, 340551 H47100096, 342973 E97300222, 338960 V96100540, 343202 E1612, 338960 V96100699, 340551 H47100194, 338962 V96300578, 338960 V96101019, 338960 V96101046, 647794 H79400003, 338962 V96301088, 338962 V96301130, 649225 H5B300008, 338962 V96301272, 343020 E0208, 343202 E0761, 343023 E0167, 340551 H47100042, 342974 E97400015, 338960 V96100301, 340469 P46900059, 340469 P46900065, 338962 V96300268, 33300472 H47200097, 338962 V96300530, 338960 V96100981, 338962 V96300106, 338960 V96101287, 650053 P05300001, 338962 V96301062, 338962 V96301064, 650053 P05300002, 338962 V96301092, 338960 V96101496, 343020 E0166, 34320208 E0052, 338962 V96301283, 33300472 H47200086, 334079 P07900196, 340469 P46900062, 643181 P18100003, 643182 P18200007, 643178 P17800006, 643181 P18100008, 643695 P69500039, 643178 P17800023, 33300482 H48200060, 643695 P69500053, 340551 H47100213, 643695 P69500102, 643182 P18200033, 340551 H55100003, 643695 P69500128, 643184 P18400055, 643695 P69500155, 643188 P18800027, 342973 E97300198, 342976 E97600133, 338960 V96100486, 338962 V96300490, 338962 V96300493, 338962 V96300102, 342975 E97501136, 342973 E97300354, 343276 E97501250, 338962 V96300677, 342975 E97501426, 33896008 V96100700, 338962 V96300766, 340551 H55100015, 338962 V96301047, 648064 H06400009, 649225 H5B400008, 647177 H17700024, 338962 V96301218, 338960 V96101464, 339101 H0093, 647177 H64717700001, 338962 V33896301395, 343020 E1032, 343202 E3578, 343202 E0781, 343202 E1382, 343202 E3863, 342976 E97600021, 343023 E0019, 343023 E0790, 337175 V07300455, 342975 E97500576, 338960 V96100399, 340469 P46900099, 338960 V96100531, 340551 H47100129, 338960 V96100709, 342975 E97501104, 338962 V96300660, 338962 V96300097, 338960 V96100992, 338960 V96101113, 338960 V96101118, 338962 V96300849, 340551 H55100020, 338962 V96301063, 338962 V96301100, 338963 V96301110, 645054 P0024, 338962 V96301080, 338962 V96301085, 647792 H79200002, 338962 V96301159, 650110 P11000012, 338962 V96301206, 650110 P11000018, 343276 E4566, 643554 V33896100009, 648282 P64828200002, 647795 H64779500001, 650110 P65011000031, 335222 P22200014, 343020 E1112, 343202 E0476, 343202 E0554, 343202 E0801, 34320208 E1375, 342975 E1628, 343202 E5015, 343023 E3601, 339101 H0062, 338960 V96100519, 342975 E97500793, 33300472 H47200098, 33300472 H47200100, 338960 V96100689, 338960 V96100690, 338962 V96300521, 342976 E97600192, 338960 V96101056, 338960 V96101080, 647794 H79400021, 338962 V33896301370, 338962 V33896301414, 343020 E0207, 338960 V96100247, 343276 E3044, 343276 E2623, 343276 E2083, 338960 V33896101560, 338962 V33896301423, 34297508 E97500441, 342975 E97500591, 343023 E1185, 343023 P05, 340551 H47100035, 33300472 H47200084, 340551 H47100027, 338960 V96100223, 33300478 H47800075, 33300476 H47600088, 338962 V96300255, 342976 E97600121, 33300472 H47200089, 342975 E97500722, 340551 H47100087, 338962 V96300322, 343276 E1183, 340551 H47100165, 338960 V96100781, 338962 V96300552, 338962 V96300764, 647794 H79400002, 343276 E6103, 647800 H80000003, 339101 H0039, 338960 V96101178, 338960 V96101322, 649225 H5B100005, 338962 V96301243, 338962 V96301244, 340551 H55100037, 647800 H80000014, 339101 H0079, 338962 V33896301410, 338962 V33896301401, 647794 H64779400027, 34297508 E0470, 343202 E1182, 343202 E1900, 34297508 E97500378, 343023 E0030, 343277 E02300057, 343277 E02300058, 343023 E0579, 338960 V96100305, 338962 V96301065, 338962 V96301188, 647794 H79400005, 339101 H48200066, 340469 P46900046, 340469 P46900055, 340469 P46900064, 340469 P46900094, 340551 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PILOT2, 334079 PROTO3, 334078 P07800200, 643180 P18000014, 645054 P18200004, 643188 P18200005, 643188 P18800003, 643188 P18800005, 643188 P18800010, 643188 P18800017, 642942 P94200001, 648282 P28200198, 643188 P69500001, 340469 P46900033, 334225 A002, 334225 A003, 334225 PILOT010, 340128 PILOT015, 334225 PILOT019, 334225 W0031, 340128 W91100026, 340128 W91100174, 340128 W91100179, 340128 W91100228, 344860 W91100063, 343020 E0001, 343020 E0061, 343020 E0073, 343020 E0344, 343020 E0534, 343020 E0612, 343020 E3717, 343276 AP2, 343202 E0158, 34327608 E1245, 343202 E20200062, 343202 E2591, 34327608 E6104, 342975 E97500688, 343023 E0634, 343023 E0914, 343277 E1121, 343023 E2430, 337175 V0002, 337175 V0005, 336036 V0006, 336036 V0018, 335860 V0116, 335860 V03600034, 337175 V07300209, 337175 V07300226, 337175 V07300232, 337175 V07300255, 337175 V07300262, 337175 V07300320, 337175 V07300362, 337175 V07300365, 337175 V07300425, 641548 V07300503, 338962 V33896300003, 339473 V87500078, 338960 V96100138, 338960 V96100201, 338960 V96101149, 338962 V96300005, 338962 V96300013, 338962 V96300017, 338962 V96300018, 338962 V96300019, 338962 V96300033, 338962 V96300034, 338962 V96300037, 338962 V96300242, 338962 V96300291, 338962 V96301134, 338962 V96301195, 338962 V96301211, 34008860 D0004, 34008860 D0014, 343186 D0015, 343073 D0066, 343186 D0245R, 34008861 D0408, 34008860 D0409, 343073 D0596, 343073 D0894, 343073 D290200026, 343073 D290200027, 337858 D858000406, 337858 D858000432, 337858 D858000474, 337858 D858000475, 337858 D858000571, 337858 D858000918, 337858 D858001010, 337858 D858001753, 343268 SE0360, 646500 X5000041, 644655 Z65500004, 649225A1 Z5A100001, 649225A1 Z5A100002, 649225A1 Z5A100003, 649225A1 Z5A100005, 647177 H17700004, 647794 H5S100001, 647783 H5S100002, 333004 H1031, 339101 H1031R, 333004 H1059, 333004 H1167, 34862708 H47200099, 33300476 H47600061, 33300482 H48200035, 33300408 H48200052, 339101 H47100215, 641764 1001-37595-A033-R005, 641764 1001-6997-A061, 641764 1001-15897-A064, 641764 1001-6997-A062, 641250 EP00118, 641764 1001-37397-A072, 641250 EP00121, 641764 1001-4007-7326, 641764 1001-37397-A071, 641764 1001-96696-A059, 641764 1001-56897-A077, 641764 1001-68096-A056, 641764 1001-56897-A076, 641250 EP00128, 641250 EP00127, 641764 1001-56897-A094, 641764 1001-56897-A092, 641250 EP00136, 641250 EP00137, 641764 1001-17797-A065, 641764 1001-17398-A100, 641250 EP00141, 641764 1001-45198-A102, 641764 1001-96197-A087, 641250 EP00143, 641764 1001-85198-A111, 641250 EP00107, 641250 EP00145, 641250 EP00138, 641250 Y250EP146, 645569 Y569P020, 641764 1001-106395-A044, 641250 EP00149, 645569 Y569P017, 641250 Y250EP151, 641250 Y250EP157, 641764 Y764EP127, 641250 Y250EP160, 641250 EP118, 641250 EP00158, 641764 1001-6899-A118, 641764 Y764P138, 641764 Y764P141, 641764 1001-75997-A083, 641764 1001-95695-A040, 641250 EP00133, 641250 EP002, 641250 EP0112, 641250 EP0125, 641250 PP4, 641250 PRE-03, 641764 1001-105192-7323, 641764 1001-25095-A028, 641764 1001-25694-A017, 641764 1001-36195-A031, 641764 1001-56797-A075, 641764 1001-65093-7330, 641764 1001-66793-7331, 641764 1001-6695-A024, 641764 1001-75493-7328, 641764 1001-75997-A081, 641764 1001-97995-A042, 641764 Y764P115, 340551 H47100032, 338960 V96100238, 343276 E1051, 338960 V96100326, 340551 H47100069, 340469 P46900079, 340469 P46900086, 340551 H47100088, 334079 P07900215, 338960 V96100611, 339473 V87500065, 64355401 V96100133, 643178 P17800028, 340551 H47100225, 340551 H47100227, 342975 E97501264, 339101 H47100166, 342975 E97501404, 33300482 H46200074, 339473 V87500099, 338960 V96101213, 338960 V96101215, 338962 V96301031, 648282 P28200048, 649225 H5B400025, 648282 P28200111, 649225 H5B500011, 338962 V96300198, 338960 V96101493, 338962 V96301208, 649225 H5B500025, 335223 P22300080, 343020 E0148, 343020 E0367, 343020 E0407, 343020 E3401, 343022 E0951, 343020 E0067, 343202 E0817, 343023 E0861, 335860 V03600023, 338960 V96100001, 338962 V96300014, 641548 V96300989, 338962 V96301099, 338960 V96100164, 340469 P46900048, 339101 H1138, 340469 P46900072, 340469 P46900101, 338962 V96300368, 340551 H47100107, 342976 E97600173, 342973 E97300314, 340551 H47100199, 338960 V96101051, 342973 E97300389, 343276 E97501139, 338962 V96300777, 647793 H79300003, 649225 H5B400032, 649225 H5B400051, 648282 P64828200004, 645054 P0238, 338960 V96100731, 343276 E3461, 342973 E97300355, 342973 E97300350, 338962 V96300897, 338962 V96300035, 338960 V96101452, 338962 V96300325, 338962 V96300236, 338962 V96301290, 338962 V96301294, 641250 EP00161, 338962 V33896301386, 338962 V33896301393, 343276 E0955, 641764 1001-107196-A001, 343023 E0770, 342973 E97300140, 340128 W91100187, 343276 E2481, 33300472 H47200092, 338960 V96100459, 338962 V96300436, 342975 E97501056, 338962 V96300634, 340551 H47100214, 643695 P69500078, 340128 W91100280, 340551 H47100220, 338960 V96100944, 643695 P69500088, 338960 V96100982, 338962 V96300293, 343276 E5698, 643695 P69500127, 647780 H78000003, 649225 H5B400010, 647800 H80000007, 340128 W91100307, 649225 H5B700003, 649225 H5B400017, 647177 H17700030, 649225 H5B400042, 650110 P11000024, 342976 E97600384, 647794 H6477940000022, 338962 V33896301378, 649225 H649225B1013, 650110 P65011000035, 343020 E02000099, 343202 E0802, 343202 E0837, 343202 E2379, 342975 E97500563, 338960 V96100231, 338960 V96100785, 643695 P69500054, 338962 V96300568, 338960 V96100957, 643182 P18200025, 643177 P17700036, 338960 V96100895, 338962 V96300717, 338960 V96100979, 643695 P69500096, 338962 V96300963, 643178 P17800069, 648282 P28200002, 645054 P0164, 338960 V96101551, 338960 V96101552, 648282 P64828200007, 338960 V96100665, 337858 D858001259, 343276 E3954, 343202 E0745, 33717508 V07300599, 33717508 V07300605, 641548 V07300607, 342975 E97500507, 338962 V96300241, 338962 V96300318, 342976 E97600153, 338962 V96300480, 343276 E2096, 338962 V96300572, 338962 V96300607, 338960 V96100937, 338960 V96101120, 338960 V96101127, 338960 V96101128, 338960 V96101129, 338960 V96101168, 338962 V96300918, 343276 E3237, 649225 H5B500003, 342973 E97300475, 338962 V96301269, 338960 V96101544, 343202 E0686, 343202 E2677, 34327608 E3511, 343023 E0787, 343023 E0789, 338960 V96101124, 33896008 V96101344, 338960 V96101404, 34008860 D0238, 34008860 D0252, 337858 D858002003, 338960 V96100183, 340551 H47100041, 338962 V96300279, 338962 V96300317, 338962 V96300351, 338960 V96100615, 340551 H47100120, 340551 H47100117, 340551 H47100131, 340551 H47100161, 340551 H47100178, 338960 V96100800, 340551 H47100217, 337858 D858001565, 342975 E97501188, 338962 V96300610, 342975 E97501266, 340551 H55100004, 647799 H79900001, 647177 H17700006, 647177 H17700012, 340551 H55100022, 338960 V96101326, 649225 H5B400050, 647794 H79400017, 338962 V33896301337, 649225 H649225B9001, 334225 PILOT007, 343202 E0957, 343202 E2730, 343023 E1122, 34008860 D0172, 34008860 D0249, 343073 D0847, 450500 D08932048, 342975 E97500602, 342973 E97300179, 338960 V96100336, 338960 V96100377, 342975 E97500689, 338960 V96100431, 338960 V96100557, 338960 V96100575, 342975 E97500875, 342975 E97500877, 338960 V96100675, 339473 V87500069, 338960 V96100771, 342975 E97501200, 338960 V96100970, 338962 V96300617, 342975 E97501303, 338960 V96101265, 338962 V96301086, 342975 E97501595, 343276 E5542, 338960 V96101538, 342975 E97501755, 342975 E97501757, 338962 V33896301394, 343020 E0263, 343022 E0691, 343202 E1215, and 343023 E1007.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. || BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
  • Source
    USFDA