Devices

hemoglobin test kits

  • Model / Serial
    FR-9120 - Lot Number: 243309  FR-9360 - Lot Numbers: 213926, 213932, 213939, 213944, 220789, 220794, 220804, 220809, 220799, 220814, 220819, 220824, 220829, 220834, 220839, 220848, 220855, 220860, 220865, 220870, 220875, 220882, 220892, 220898, 228304, 228309, 228314, 228319, 228325, 228330, 228335, 228341, 228348, 228353, 228358, 228363, 228368, 228374, 228379, 228386, 228391, 228396, 229401, 228406, 234161, 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234210, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 238917, 234267, 234272, 234277, 238920, 238923, 238926, 238929, 238932, 238946, 238950, 238953, 238960, 238963, 242331, 242334, 242334.   FR-9400 - Lot Numbers: 213941,   220791, 220901, 220806, 220811, 220801, 220816, 220826, 220831, 220836, 220841, 220857, 220862, 220902, 220872, 220894, 220900, 228306, 228316, 228327, 228332, 228344, 228350, 228355, 228360, 228365, 228376, 228381, 228388, 228398, 228403, 228408, 2234192.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (The product was distributed to firms located in AR, AZ, CA, CO,FL, GA, HI, IA, IL, IN, KS, KY,LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV )and worldwide (to 12 foreign accounts).
  • Product Description
    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.
  • Manufacturer
    PerkinElmer LAS Inc
  • 1 Event

Manufacturer

PerkinElmer LAS Inc
  • Manufacturer Address
    PerkinElmer LAS Inc, 3985 Eastern Rd, Norton OH 44203-6215
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Hemoglobin Test Kits
  • Model / Serial
    Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
  • Product Description
    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
  • Manufacturer
    PerkinElmer LAS Inc