Events

Device Recall SickleScan 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MichClone Associates, Inc. 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
    61384
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1503-2012
  • 사례 시작날짜
    2012-02-23
  • 사례 출판 날짜
    2012-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108090
  • 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
    Test, sickle cell - Product Code GHM
  • 원인
    Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. when the powders are opened, the pressure from within the vial releases a small amount of powder into the air. this powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. investigation found no affect on the perf.
  • 조치
    Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.

Device

Device Recall SickleScan
  • 모델명 / 제조번호(시리얼번호)
    Lot# 1187, expiration date: 7/13  Catalog No.13-2101, Powder Lot # 1171 (part of kit)
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. || For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.
  • Manufacturer
    MichClone Associates, Inc.

Manufacturer

MichClone Associates, Inc.
  • 제조사 주소
    MichClone Associates, Inc., 680 Ajax Drive, Madison Heights MI 48071-2414
  • Source
    USFDA