Events

Device Recall N acetylprocainamide reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Operations, 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
    54624
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2386-2010
  • 사례 시작날짜
    2010-02-05
  • 사례 출판 날짜
    2010-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88804
  • 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
    Analyzer, enzyme, for clinical use - Product Code LAN
  • 원인
    The n-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. the correct expiration date for the lot is 1/31/2011.
  • 조치
    Roche issued an "Urgent Medical Device Removal" letter dated February 2010 to consignees identifying the issue and affected product. Customers were requested to complete the attached form and return in to the firm to obtain replacement product. After receipt of replacement reagent, the customer should discard the affected product product. If unaffected lots are not available, customers may use the affected lot until replacement product is received. Use of the affected product before the corrected expiration date of January 31, 2011 should not produce erroneous test results. Roche Diagnostics Technical Support can be contacted at 1-800-428-2336.

Device

Device Recall N acetylprocainamide reagent
  • 모델명 / 제조번호(시리얼번호)
    14456200
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.
  • 제품 설명
    ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA