Device Recall FB 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
    72786
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0470-2016
  • 사례 시작날짜
    2015-11-18
  • 사례 출판 날짜
    2015-12-23
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-03-28
  • 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, general nutrient broth - Product Code JSC
  • 원인
    The firm is recalling fb broth cat. no. k31, lot no. 15231 because of potential burkholderia fungorum contamination.
  • 조치
    Hardy Diagnostic notified Customers via phone on November 18, 2015, followed up with written notifications being sent via first class, email, or facsimile. Customers were instructed to destroy the recalled product according to local regulations for nonhazardous waste if uninoculated or as medical waste if inoculated. and to discard any remaining tubes of the recalled lot. Any remaining product on hand the firm stated would be replaced. The firm stated to customers that they would follow-up the phone conversation with written communication and requested a full name, and email or fax number. We sincerely apologize for the inconvenience. Thank you in advance for completing the attached form. Please feel free to contact our Technical Services Department if you have not received your replacements or if you have additional questions about this notification. Technical Services can be reached at (800) 266-2222, option 2 or via email at TechService@HardyDiagnostics.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cat. no. K31 Lot no.15231
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US. Distribution to the states of : CA, WI, MD and UT. .
  • 제품 설명
    FB Broth, 10ml || (Fastidious Bacteria Broth) || Cat. no: K31 Lot: 15231 || A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
  • Manufacturer

Manufacturer

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