Device Recall Calloway LabsMultiDrug 9 Panel Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alere San Diego 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
    59101
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2881-2011
  • 사례 시작날짜
    2011-06-10
  • 사례 출판 날짜
    2011-07-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-04-04
  • 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
    Enzyme Immunoassay, Amphetamine - Product Code DKZ
  • 원인
    Alere is initiating a voluntary recall on the listed lots of multi-drug 9 panel integrated cup manufactured by alere for sole use by calloway labs due to a mistake that occurred while processing the order, these products were incorrectly labeled as clia waived, when in fact the devices are classified as moderately complex. therefore these devices are misbranded.
  • 조치
    Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers. The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere. For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog Number: DOA-197-201-19-0NW506A,   Lot/Unit Codes: DOA1040725, DOA1040758, DOA1040784, DOA1040669 & DOA1040689
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution including the states of MO and MA.
  • 제품 설명
    Calloway LabsMulti-Drug 9 Panel Assay || A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA