Events

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    31502
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0912-05
  • 사례 시작날짜
    2005-03-16
  • 사례 출판 날짜
    2005-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38016
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Activated Whole Blood Clotting Time - Product Code JBP
  • 원인
    Misidentification of celite act cartridge as kaolin act cartridge in the analyzer.
  • 조치
    The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.

Device

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
  • 모델명 / 제조번호(시리얼번호)
    i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world).  Lot Numbers: R04174B; R04175; R04175A; R04183; R04183A; R04183B; R04183C; R04190A; R04190B; R04205; R04205A; R04212A; R04212B; R04233; R04239; R04245; R04245A; R04245B; R04253; R04261; R04261A; R04262; R04274; R04274A; R04275; R04293; R04293A; R04294; R04294A; R04305; R04305A; R04305B; R04306; R04309; R04309A; R04315; R04315A; R04315B; R04322; R04323; R04323A; R04329; R04337; R04337A; R04342; R04343; R04350; R04350A; R04350B; R05006; R05014; R05014A; R05032B; R05032C; R05043; R05043A; R05044; R05048B; R05048C.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 government and military accounts.
  • 제품 설명
    i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA