Device Recall HardyCHROM MRSA 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
    71804
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2463-2015
  • 사례 시작날짜
    2015-07-09
  • 사례 출판 날짜
    2015-08-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-11-10
  • 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 hardychrom mrsa due to a report of the potential for breakthrough of the methicillin-sensitive staphylococcus aureus (mssa) qc strain, atcc 29213 on the identified lot.
  • 조치
    The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cat no. G307 Lot no. H15155
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
  • 제품 설명
    HardyCHROM MRSA || Cat no: G307 Lot no: H15155 || Expires: 2015-08-13 || Container Type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2-8C on receipt. Light Sensitive. || In vitro diagnostic || www.HardyDiagnostics.com
  • Manufacturer

Manufacturer

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