Events

Device Recall PF4 Concentrated Wash 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Genetic Testing Institute,inc 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
    70012
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1001-2015
  • 사례 시작날짜
    2014-12-15
  • 사례 출판 날짜
    2015-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132110
  • 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
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • 원인
    Some lots of pf4 concentrated wash (10x) are a slightly more dilute concentration. this may lead to slightly increased optical density (od) values. samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
  • 조치
    Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to waukeshatechsupport@immucor.com. Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com.

Device

Device Recall PF4 Concentrated Wash
  • 모델명 / 제조번호(시리얼번호)
    Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
  • 제품 설명
    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and || 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) || The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The || PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react || with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic || compounds. The PF4 IgG kit contains all of the reagents necessary to perform || the assay.
  • Manufacturer
    Genetic Testing Institute,inc

Manufacturer

Genetic Testing Institute,inc
  • 제조사 주소
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA