Devices

Device Recall ARCHITECT B12 Reagent

  • Model / Serial
    lot numbers 33079M200, 33079M201
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany and Australia
  • Product Description
    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories MPG
  • 1 Event

Manufacturer

Abbott Laboratories MPG
  • Manufacturer Address
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA

One device with a similar name

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Device Recall ARCHITECT B12 Reagents
  • Model / Serial
    List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300; List 6C09-25, lots 11002M301, 16051M201, 18288M301
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.
  • Product Description
    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD