Events

Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microgenics 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
    62987
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0379-2013
  • 사례 시작날짜
    2012-08-20
  • 사례 출판 날짜
    2012-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112207
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • 원인
    In house testing confirmed that ck-ms and insulin claimed in both omni immune and omni immune pro products are displaying reduced stability.
  • 조치
    Microgenics Corporation sent a Recall Notification letter dated August 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed that immediate attention is required and identify the two affected constituents. The letter contains a list of the affected product with their catalog number, lot number and expiration date and request that the CK-MB and Insulin use be discontinued. The remaining components of the product may be used. Evaluate quality controls according to your laboratory procedures. Retain a copy of the letter for your laboratory records. If the product was forwarded to another laboratory, provide them with a copy of the letter. Complete the attached Recall Response form and return within 5 days. Questions may be directed to 1-800-232-3342.

Device

Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO
  • 모델명 / 제조번호(시리얼번호)
    MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014.  MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
  • 제품 설명
    Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; || Liquid Assayed Integrated Immunoassay Control. || Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. || .
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • 제조사 주소
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA