Events

Device Recall Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Catch Incorporated 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
    60811
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0921-2012
  • 사례 시작날짜
    2011-06-27
  • 사례 출판 날짜
    2012-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106524
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • 원인
    Homogeneous enzymic homocysteine reagent two part reagent method will not calibrate due to reagent r1 had prematurely decayed.
  • 조치
    Catch Inc. sent an "URGENT-PRODUCT RECALL" letter dated 27 June 2011 to one sole customer. The letter described the product, problem, and actions to be taken by the customer. A reply form was attached to the letter for the customer to complete and return via fax at 425-402-8954. Please contact the firm at 425-402-8960 for questions regarding this recall.

Device

Device Recall Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method
  • 모델명 / 제조번호(시리얼번호)
    Lot D1101303
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product distributed in PA.
  • 제품 설명
    Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. || A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
  • Manufacturer
    Catch Incorporated

Manufacturer

Catch Incorporated
  • 제조사 주소
    Catch Incorporated, 11822 N Creek Pkwy N Ste 107, Bothell WA 98011-8203
  • Source
    USFDA