Events

Device Recall Test Kit 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
    48734
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0448-2009
  • 사례 시작날짜
    2007-01-18
  • 사례 출판 날짜
    2009-01-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72016
  • 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
    Reagent Test Kit - Product Code LPS
  • 원인
    A high homocysteine level can be reported as falsely low.
  • 조치
    On 01/18/07 an "URGENT: PRODUCT CORRECTIVE ACTION" letter was sent to the consignees. The letter states the circumstances in which a high homocysteine rate can result in a false low homocysteine rate, a work around for the problem which a flag must be programmed into the user defined homocysteine test parameters and instructions to advise their customers about the situation was addressed in the letter so the consignees can take the recommended corrective action. A confirmation sheet was included with the letter to be signed by a representative of each distributor and returned to Catch Inc. Contact Catch Inc. at 1.425.402.8960 for assistance.

Device

Device Recall Test Kit
  • 모델명 / 제조번호(시리얼번호)
    Catch Inc. - Lot Numbers and expiration dates include L05037 2007-05, B06003 2007-08, F06011 2007-12 and H06021 200802. Equal Diagnostics -Lot Number and expiration date include F06011 2007-12. First digit is the month of manufacture, A = Jan, B = Feb, but I is not used. Second and third digits are the year of manufacture, 05 = 2005. The remaining digits are sequential numbers for the next lot.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA and PA.
  • 제품 설명
    Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.
  • Manufacturer
    Catch Incorporated

Manufacturer

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