Events

Device Recall PerkinElmer 226 Sample Collection Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PerkinElmer Health Sciences, 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
    77668
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2756-2017
  • 사례 시작날짜
    2017-05-31
  • 사례 출판 날짜
    2017-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157403
  • 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
    Newborn screening specimen collection paper - Product Code PJC
  • 원인
    Perkinelmer 226 sample collection devices lot number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
  • 조치
    PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.

Device

Device Recall PerkinElmer 226 Sample Collection Device
  • 모델명 / 제조번호(시리얼번호)
    lot numbers 317113 and 317114
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the state of : AL
  • 제품 설명
    PerkinElmer 226 Sample Collection Device || The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • 제조사 주소
    PerkinElmer Health Sciences, Inc., 17 P & N Drive, Greenville SC 29611
  • 제조사 모회사 (2017)
    Perkin Elmer Inc.
  • Source
    USFDA