Healing Labs¿ Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Core Brands 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
    32525
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1042-05
  • 사례 시작날짜
    2005-06-22
  • 사례 출판 날짜
    2005-07-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2005-11-16
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • 원인
    Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
  • 조치
    The recalling firm notified distributors by phone on 06/17/05 to hold product and followed with a letter and fax to distributors and direct account retailers on 06/21/05. Notification instructed distributors and retailers to discontinue selling the product and return product. Distributors were requested to notify all of their consignees with the 'retailer alert' notification provided.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..
  • 제품 설명
    Healing Labs¿ Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Core Brands, 1301 Wicomico Street, Baltimore MD 21230-2000
  • Source
    USFDA