Events

Device Recall 10 Buffered Formalin Phosphate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ThermoFisher Scientific Co., LLC 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
    48601
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2159-2008
  • 사례 시작날짜
    2008-05-01
  • 사례 출판 날짜
    2008-08-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71704
  • 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
    Neutral Buffered Formalin - Product Code IFP
  • 원인
    Assay tests on retention sample of 10% buffered formalin phosphate showed it to be 3.417%, which is below the specification of 4-5%.
  • 조치
    Urgent: Product Recall notification letters were sent by US mail on May 1, 2008. The letters asked that those in receipt of the product check their stock for this product, destroy any of the material that remains from the referenced lot, and then contact their local customer service center for a replacement. The letter also states that the appropriate corrective measures have already been instituted to prevent a recurrence.

Device

Device Recall 10 Buffered Formalin Phosphate
  • 모델명 / 제조번호(시리얼번호)
    Lot 075923
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and Canada.
  • 제품 설명
    10% Buffered Formalin Phosphate; Certified || For laboratory and manufacturing use only, not for drug, food or household use. || Do not Transfer to an unmarked container. || Catalog numbers: SF100-4, SF100-20 || Fisher Scientific, Fail Lawn, NJ 07410
  • Manufacturer
    ThermoFisher Scientific Co., LLC

Manufacturer

ThermoFisher Scientific Co., LLC
  • 제조사 주소
    ThermoFisher Scientific Co., LLC, 1 Reagent Ln, Fair Lawn NJ 07410-2802
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA