Events

Device Recall Cobas b 123 POC system 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
    63680
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0522-2013
  • 사례 시작날짜
    2012-11-14
  • 사례 출판 날짜
    2012-12-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114521
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • 원인
    It has been determined that cobas b 123 fluid pack coox cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. internal investigations found the altered thickness of the cuvette was due to production equipment settings. cuvettes were produced within specifications, but within the upper.
  • 조치
    Roche sent an Urgent Medical Device Removal (UMDR12-268) notification and faxback form on November 14, 2012, to all affected consignees. Customers were requested to discontinue the use of cobas b 123 Fluid Pack COOX, 200 lots 21426121 and21426171 and discard the product per local regulations. Customers were instructed to use the enclosed faxback form to order replacement product at 1-800-722-7222. For questions customers were instructed to contact Roche Diagnostics Technical Support at 1-800-526-2272. For questions regarding this recall call 317-521-3966.

Device

Device Recall Cobas b 123 POC system
  • 모델명 / 제조번호(시리얼번호)
    Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including NE and AZ.
  • 제품 설명
    Cobas b 123 POC system || cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA