Events

MAS Urinalysis 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Thermofisher Scientive 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
    66739
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0383-2014
  • 사례 시작날짜
    2013-10-29
  • 사례 출판 날짜
    2013-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123223
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • 원인
    Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for lot: ua1514011.
  • 조치
    ThermoFisher Scientific, sent an Urgent Medical Device Field Correction letter dated October 29, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use, segregate and discard the affected product. Customers with questions were instructed to contact mas.controls@thermofisher.com. For question regarding this recall call 1-800-232-3342.

Device

MAS Urinalysis
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: UA1514011
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
  • 제품 설명
    MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA || MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
  • Manufacturer
    Thermofisher Scientive

Manufacturer

Thermofisher Scientive
  • 제조사 주소
    Thermofisher Scientive, 46360 Fremont Blvd, Fremont CA 94538-6406
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA