Device Recall VRE Broth 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hardy Diagnostics 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
    71602
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2279-2015
  • 사례 시작날짜
    2015-06-26
  • 사례 출판 날짜
    2015-07-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • 원인
    Hardy diagnostics is recalling macconkey agar with ciprofloxacin, brain heart infusion broth with ciprofloxacin 1 ug, mdr acinetobacter, bea with azide and vancomycin, bea agar with vancomycin, gentamicin, and amphotericin b, bea broth with vancomycin, and vre broth due to lack of 510(k) clearance.
  • 조치
    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com. Follow-up calls will be made to customers who do not respond.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    U.S. Nationwide Distribution and the country of: Canada
  • 제품 설명
    Hardy Diagnostics || VRE Broth, 5ml || container type: 16x100mm tube || packaged: 20 tubes/box || fill: 5ml || Product Usage: || BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • 제조사 모회사 (2017)
  • Source
    USFDA