Events

Device Recall Chemistry Wash1 REF 10680 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medica Corporation 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
    79264
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1149-2018
  • 사례 시작날짜
    2017-11-21
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161792
  • 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
    Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
  • 원인
    The firm has initiated a field recall of the wash1 kit ref 10680 due to reported inconsistent lipase values when analyzing patient samples. the firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (trig) assay if they are on the same worklist.
  • 조치
    Firm emailed all consignees and instructed them to remove/discard affected wedges (bottles) and contact Medica for immediate replacement 1 Immediately discontinue use of the Wash1 wedges (REF 10680) (Lot# listed above) and discard any remaining kits/wedges. 2. Please discuss possible concerns about lipase results achieved using these lots of Wash wedges with your laboratory manager and/or clinician in order to decide on appropriate measures. Report any concerns to Medica for evaluation and review. 3.Submit claims for replacement of affected product to your authorized Medica EasyRA dealer. For further questions, please call (781) 541-7560.

Device

Device Recall Chemistry Wash1 REF 10680
  • 모델명 / 제조번호(시리얼번호)
    Lots 16279, 17045 and 17215
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide and US Distribution.
  • 제품 설명
    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 || Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
  • Manufacturer
    Medica Corporation

Manufacturer

Medica Corporation
  • 제조사 주소
    Medica Corporation, 5 Oak Park Dr, Bedford MA 01730-1430
  • 제조사 모회사 (2017)
    Medica Corporation
  • Source
    USFDA