Manufacturers

PerkinElmer LAS Inc

3 devices in the database

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.
Neonatal Total Galactose Test Kit.
  • Model / Serial
    Lot #244468
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
  • Product Description
    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
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.