Events

PerkinElmer 226 Sample Collection Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Perkin Elmer 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
    66310
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0030-2014
  • 사례 시작날짜
    2013-09-05
  • 사례 출판 날짜
    2013-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122029
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • 원인
    Some devices may be contaminated on the back side of the device with glue in the blood application area.
  • 조치
    The firm, Perkin Elmer, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated September 5, 2013 via email to its consignees. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately notify all submitting facilities and personnel that have received the PerkinElmer 226 Sample Collection Device of the potential glue contamination and to distribute the enclosed record of actions form to all submitting facilities/personnel and encourage them to perform the inspection activities as listed in the letter; and complete and return the enclosed Recall Response Form return it to PerkinElmer Health Sciences via fax to: 864-299-8797 or email to: Rick.Haines@perkinelmer.com. Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).

Device

PerkinElmer 226 Sample Collection Device
  • 모델명 / 제조번호(시리얼번호)
    Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution in OH
  • 제품 설명
    Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. || The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
  • Manufacturer
    Perkin Elmer Health Sciences, Inc.

Manufacturer

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