Events

Device Recall Cobas 8000 Modular Analyzer Series 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
    63577
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0473-2013
  • 사례 시작날짜
    2012-11-01
  • 사례 출판 날짜
    2012-12-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114234
  • 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, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    On cobas c 701 and cobas c 702 modules of the cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. this may affect patient sample and controls recovery for the following tests: alkaline phosphatase (alp2), alanine aminotransferase (alt), bicarbonate (co2-l), creatinine (c.
  • 조치
    On 11/01/2012 an "Urgent Medical Device Correction" notification was sent via UPS Ground (receipt required) to consignees. The device issue was described and recommended actions were provided. A Roche Field Application Specialist will install the new e-barcode during a scheduled visit. Customers also will have an option to install the new e-barcodes themselves, following the instructions provided in the notification. A Software update will be released when available. Customers may contact Technical Support at 1-800-428-2336 for more information.

Device

Device Recall Cobas 8000 Modular Analyzer Series
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190; Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate (P5P) activation 05850797190; Bicarbonate Liquid 05446376190; Creatinine Jaff¿ Gen.2 05168597190; C-Reactive Protein Gen.3 05172373190; and Urea/BUN 05171873190. Serial Number(s): 0917-10, 1020-04, 1020-05, 1021-03, 1021-04, 1021-07, 1021-08, 1023-06, 1023-09, 1023-10, 1024-03, 1024-04, 1024-05, 1024-09, 1025-02, 1025-05, 1025-07, 1025-09, 1026-01, 1026-02, 1027-09, 1028-01, 1028-07, 1030-09, 1031-05, 1031-09, 1032-09, 1032-10, 1033-04, 1033-05, 1107-06, 1109-02, 1109-03, 1111-07, 1111-08, 1112-02, 1112-04, 1115-06, 1115-07, 1115-08, 1115-10, 1117-04, 1117-07, 1118-02, 1126-02, 1126-03, 1126-04, 1127-01, 1127-02, 1127-06, 1127-07, 1138-03, 1138-04, 1139-04, 1139-05, 1139-06, 1140-02, 1140-03, 1140-04, 1140-05, 1140-10, 1141-08, 1141-09, 1142-02, 1142-03, 1142-04, 1143-01, 1143-02, 1143-03, 1143-04, 1143-05, 1143-06, 1144-05, 1146-04, 1146-05, 1146-06, 1146-07, and 1146-08.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI.
  • 제품 설명
    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

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