Device Recall HardyCHROM SS Agar 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
    70767
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1444-2015
  • 사례 시작날짜
    2015-03-04
  • 사례 출판 날짜
    2015-04-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-13
  • 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, selective and differential - Product Code JSI
  • 원인
    The firm is recalling hardychrom ss, cat. no. g327 lot no. 15037 due to a report of possible lack of color development in shigella organisms in the referenced lot.
  • 조치
    On 03/12/2015 the firm sent recall notification letters to customers. The firm's letter informs customers of the reason for recall, and requests that they discard any remaining stock of the recalled lot. The firm continues to request that even though the customer has been informed of the necessary actions that they still take a moment to complete, sign, and fax back the enclosed form stating their compliance with the above action to the attention of their Quality Assurance Department at (805) 614-9274. The firm stated that the form is required for their records and need to document the full quantity received, used and/or discarded. For replacements or credit to please contact the Customer Service Department at (800) 266-2222 and select option 1. The firm states that replacements will be sent out at no charge to customers, or a credit will be applied to the invoice. For any additional questions the firm states to contact Technical Services at (800) 266-2222, option 2 or e-mail at techservice@hardydiagnostics.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot no. 15037, Expires: 00-00-2000
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
  • 제품 설명
    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar || (HardyCHROM Salmonella Shigella) || Cat no: G327 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2 to 8 degrees C. on receipt in dark || A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
  • Manufacturer

Manufacturer

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