Device Recall ARCHITECT Folate Specimen Diluent

  • 모델명 / 제조번호(시리얼번호)
    List 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y, 05081M100Y, 07465M300Y and 10587M200Y. These diluent lots were packaged in the following reagent kit lots: List 6C12-20 (4 x 100 tests), lots06537M100 and 09888M100; List 6C12-25 (100 tests), lots 06537M101and 05081M100; List 6C12-30 (4 x 500 tests), lots 07465M300 and 10587M200.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.
  • 제품 설명
    ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30); Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA