Events

MicroScan Pos Combo Panel Type 33 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter, 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
    70904
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1524-2015
  • 사례 시작날짜
    2014-04-08
  • 사례 출판 날짜
    2015-04-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135479
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • 원인
    Siemens investigation confirmed that a portion one lot of panel pos combo 33 lot was packaged without desiccants. the substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch.
  • 조치
    Siemens sent an Urgent Medical Device Recall letter dated April 8, 2014, to all affected customers. Letters advised users of the recalled product with catalog number, Siemens Material Number and Lot number as well as the reason for recall. The risk to health was explained as well as the recommendation for discussing the content of the letter with the medical director regarding the need to review previous test results. Customers are asked to discontinue use and discard any remaining inventory of the PC33 panel 2014-09-12. All other lot numbers are not impacted. The attached confirmation receipt is to be completed and returned and the letter should remain with laboratory records. Questions should be directed to Siemens Customer Care Center. For further questions call (916) 374-3031.

Device

MicroScan Pos Combo Panel Type 33
  • 모델명 / 제조번호(시리얼번호)
    Catalog number B10170211; Siemens Material number (SMN): 1071530, lot number 2014-09-12.: Expiration date 2014-09-12.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Puerto Rico and to the states of : CT, GA, NC, OK, NY, SC, KY, TN, CA, WA, OR, NJ, OH, PA, FL, MI, TX, WI, MO and NH.
  • 제품 설명
    MicroScan Pos Combo Panel Type 33 (PC33): || Catalog number B1017-211 || MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing || aerobic and facultative anaerobic gram-positive bacteria.
  • Manufacturer
    Beckman Coulter, Inc.

Manufacturer

Beckman Coulter, Inc.
  • 제조사 주소
    Beckman Coulter, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA