Devices

Device Recall PrepStain System

  • Model / Serial
    SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
  • Product Description
    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). || The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
  • Manufacturer
    Tripath Imaging, Inc.
  • 1 Event

Manufacturer

Tripath Imaging, Inc.
  • Manufacturer Address
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA

3 devices with a similar name

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Device Recall PrepStain System
  • Model / Serial
    Catalog # 490670: These items are not serially tracked.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
  • Product Description
    PrepStain Kit: 1.2 DiTi Cone. || The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
  • Manufacturer
    Tripath Imaging, Inc.
Device Recall PrepStain System
  • Model / Serial
    Catalog # 491074: Serial/Lot # 110805MA
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
  • Product Description
    PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. || The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
  • Manufacturer
    Tripath Imaging, Inc.
Device Recall PrepStain System
  • Model / Serial
    Catalog # 490100; Serial/Lot #s: USPS200576, USPS200577, USPS200578, USPS200583, USPS200584, USPS200585, USPS200586, USPS200587, USPS200588, USPS200589, USPS200590, USPS200591,USPS200592, USPS200593, USPS200594, USPS200595, USPS200596, USPS200597,USPS200598, USPS200599, USPS200600, USPS200601, USPS200602, USPS200603, USPS200604, USPS200605, USPS200606, USPS200607, USPS200608, USPS200609,USPS200610, USPS200611, USPS200612, USPS200613, USPS200614, USPS200615, USPS200616, USPS200617, USPS200618, USPS200619, USPS200620, USPS200621,USPS200622, USPS200623, USPS200624, USPS200625, USPS200626, USPS200627,USPS200628, USPS200629, USPS200630, USPS200631, USPS200632, USPS200633, USPS200634, USPS200635, USPS200636, USPS200637, USPS200638, USPS200639,USPS200640, USPS200641, USPS200642, USPS200643, USPS200644, USPS200645, USPS200646, USPS200647, USPS200648, USPS200649, USPS200650, USPS200651, USPS200652, USPS200653, USPS200654, USPS200655, USPS200656, USPS200657, USPS200658, USPS200659, USPS200660, USPS200661, USPS200662, USPS200663, USPS200664, USPS200665, USPS200666, USPS200667, USPS200668, USPS200669, USPS200670, USPS200671, USPS200672, USPS200673, USPS200674, USPS200675, USPS200676, USPS200677, USPS200678, USPS200679, USPS200680, USPS200681, USPS200682, USPS200683, USPS200684, USPS200685, USPS200686, USPS200687, USPS200688, USPS200689, USPS200690, USPS200691, USPS200692, USPS200693, USPS200694, USPS200695, USPS200696, USPS200697, USPS200698, USPS200699, USPS200701, USPS200702, USPS200703, USPS200704, USPS200705, USPS200706, USPS200707, USPS200708, USPS200709, USPS200710, USPS200711, USPS200712, USPS200713, USPS200714, USPS200715, USPS200716, USPS200717, USPS200718, USPS200719, USPS200720, USPS200721, USPS200722, USPS200723, USPS200724, USPS200725, USPS200726, USPS200727, USPS200728, USPS200729, USPS200730, USPS200731, USPS200732, USPS200733, USPS200734, USPS200735, USPS200736, USPS200737, USPS200738, USPS200739, USPS200740, USPS200741, USPS200742, USPS200743, USPS200744, USPS200746, USPS200748, USPS200751, USPS200756, USPS200757, USPS200758, USPS200759, USPS200760, USPS200761, USPS200762, USPS200763, USPS200764, USPS200765, USPS200766, USPS200767, USPS200768, USPS200769, USPS200770, USPS200771, USPS200772, USPS200773, USPS200774, USPS200775, USPS200776, USPS200777, USPS200778, USPS200781, USPS200783 and USPS200787.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
  • Product Description
    PrepStain Slide Processor. || The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
  • Manufacturer
    Tripath Imaging, Inc.