Device Recall Jologic InPlex CF Molecular Test 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hologic, 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
    73747
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1580-2016
  • 사례 시작날짜
    2016-03-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-09
  • 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
    System, cystic fibrosis transmembrane conductance regulator, gene mutation detection - Product Code NUA
  • 원인
    Complaints of false positive het mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
  • 조치
    Customer notification letters were sent 03/31/16. Customers were instructed to immediately discontinue the use of the affected lot numbers. If a HET or MUT result was reported with the affected lots, Hologic recommends that customers notify the recipient of the result and request the patient be retested with another test method. Any HET or MUT results that were previously retested and reported out as negative do not require further testing. The firm requests that customers segregate any remaining inventory of all affected lots listed on the Customer Response Form. After segregation is complete reconcile the number of units (ASR Card or IVD Molecular Test Kit) which remain in inventory upon receipt of notification against the number originally shipped to site, and destroy all remaining inventory of the affected lots. Document the following in the appropriate fields on the Customer Response Form: 1. If have zero of the affected products on hand check the first box. 2. If have some inventory of the affected products on hand check the second box and then document the quantity on hand below, in the Qty On-Hand column. Note: When counting the number of units remaining in inventory count each unit (ASR Card box or IVD Molecular Test Kit), whether partial or full, as a unit. 3. Print name, phone and email address, in case the firm needs to follow up. 4. Sign and date the form. Signing acknowledges compliance with this recall notification, including destroying all remaining inventory of the affected products. When this documentation is complete fax the CRF to Hologic Technical Support using fax number: 858-410-8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com. If laboratory has shared any of the affected cards noted in the CRF with another laboratory contact Hologic Technical Support immediately using the phone number below, so that Hologic may contact the other laboratory t

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
  • 제품 설명
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hologic, Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • 제조사 모회사 (2017)
  • Source
    USFDA