Events

Device Recall Hemoglobin Test Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PerkinElmer LAS 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
    29485
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1158-04
  • 사례 시작날짜
    2004-06-29
  • 사례 출판 날짜
    2004-07-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33827
  • 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
    System, Analysis, Electrophoretic Hemoglobin - Product Code JBD
  • 원인
    Hemoglobin test kit catholyte solution generating false positive results, were distributed.
  • 조치
    The firm contacted their customers via telephone and notified them of the recall on 6/29/2004. A follow-up recall letter was also issued on 6/29/2004. The letter requests that the customer either destroy the product or return it to the firm for replacement. Also attached for completion and to be faxed back to the recalling firm, is a questionaire which documents the customer''s receipt of the product and recall letter; any reports of illness or injury in connection with the use of the product; and the customer''s proposed disposition of the kits i.e. return or destruction. Additional follow-up with all non-responding customers will take place in 2 weeks.

Device

Device Recall Hemoglobin Test Kits
  • 모델명 / 제조번호(시리얼번호)
    Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
  • 제품 설명
    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
  • Manufacturer
    PerkinElmer LAS Inc

Manufacturer

PerkinElmer LAS Inc
  • 제조사 주소
    PerkinElmer LAS Inc, 3985 Eastern Rd, Norton OH 44203-6215
  • Source
    USFDA