Events

EPO Calibration Verifiers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nichols Institute 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
    33774
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0136-06
  • 사례 출판 날짜
    2005-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42419
  • 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
    Assay, Erythropoietin - Product Code GGT
  • 원인
    Some units in lot 30-500953 (calibration verifier 2) are mislabeled as calibration verifier 3. some units of lot 30-500953 (calibration verifier 3) are mislabeled as calibration verifier 2.
  • 조치
    Written notification was sent via fax on 9/29/05. If receipt was not confirmed, written version of notification was mailed via next day delivery. NID intends to track the response forms and if after 2 weeks after distribution not all forms have been received, NID will conduct a follow-up phone call and resend if necessary.

Device

EPO Calibration Verifiers
  • 모델명 / 제조번호(시리얼번호)
    Kit lots# 63-502081, 63-502081A contain Calibration Verifiers 1, 2, and 3. Lot #30-500952 is specific to Calibration Verifier 2; Lot #30-500953 is specific to Calibration Verifier 3.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, IN, WA
  • 제품 설명
    Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
  • Manufacturer
    Nichols Institute Diagnostics

Manufacturer

Nichols Institute Diagnostics
  • 제조사 주소
    Nichols Institute Diagnostics, 1311 Calle Batido, San Clemente CA 92673-6316
  • Source
    USFDA