Events

Device Recall Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027201 panels. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    64699
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1272-2013
  • 사례 시작날짜
    2013-03-06
  • 사례 출판 날짜
    2013-05-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116809
  • 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
    Panels, test, susceptibility, antimicrobial - Product Code LTT
  • 원인
    Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with a. agalactiae affecting multiple antimicrobial agents on microscan microbiology systems.
  • 조치
    Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer. As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing for testing conducted in the last twelve months. Confirmation of receipt of this letter is required. Attached you will find a form indicating you have received and understood the information. We would greatly appreciate your assistance in notifying us that you have received the information by taking a moment to complete and return the form below. If you require further information or assistance, please contact your local Siemens Healthcare Diagnostics Representative. Please forward this notification to anyone to whom you may have distributed this product. We apologize for the inconvenience that this situation has caused. For further questions please call 1-800-677-7226 Option 1 (USA/Canada) Thank you for your patience and continued support.

Device

Device Recall Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027201 pan...
  • 모델명 / 제조번호(시리얼번호)
    All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including Puerto Rico.
  • 제품 설명
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. || .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA