Device Recall IRISpec" CA/CB twopart urine chemistry control twin set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Iris 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
    62555
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2124-2012
  • 사례 시작날짜
    2012-07-09
  • 사례 출판 날짜
    2012-08-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-01-27
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • 원인
    The firm recalled after it received complaints of irispec ca/cb two part urine chemistry control, 101131-12, where the nitrite results read negative for the part b control, which should be positive.
  • 조치
    The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.

Device

  • 모델명 / 제조번호(시리얼번호)
    Iris Diagnostics part number 800-0074, lot number 131-12.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. || Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA