Device Recall remel Mueller Hinton Agar w/4 NaCl w/6 mcg/ml Oxacillin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Remel, 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
    54042
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0644-2010
  • 사례 시작날짜
    2009-12-08
  • 사례 출판 날짜
    2010-01-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-07-12
  • 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, mueller hinton agar/broth - Product Code JTZ
  • 원인
    The product may fail to adequately grow methicillin resistant staphylococcus aureus atcc 43300 and staphylococcus aureus atcc 33591.
  • 조치
    The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 833352, Exp. 2009.12.22.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. || The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA