Events

Device Recall Pointe Scientific CRP(HS) Wide Range Control and Wide Range Standard Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtest Holdings, 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
    77451
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2631-2017
  • 사례 시작날짜
    2009-07-21
  • 사례 출판 날짜
    2017-06-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156076
  • 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
    C-reactive protein, antigen, antiserum, and control - Product Code DCK
  • 원인
    Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/l.
  • 조치
    Technical Bulletin sent notification on July 21, 2009, to affected consignees via e-mail, fax and US Mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. Customers with questions were instructed to contact Pointe Scientific's Technical Service Department at 1-800-757-5313. For questions regarding this recall call 800-757-5313.

Device

Device Recall Pointe Scientific CRP(HS) Wide Range Control and Wide Range Standard Set
  • 모델명 / 제조번호(시리얼번호)
    Model #'s C7568-CTL and C7568-STD  Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
  • 제품 설명
    Pointe Scientific CRP(HS) Wide Range Control Set and || Pointe Scientific CRP(HS) Wide Range Standard Set || 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
  • Manufacturer
    Medtest Holdings, Inc.

Manufacturer

Medtest Holdings, Inc.
  • 제조사 주소
    Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
  • 제조사 모회사 (2017)
    Medtest Holdings Inc
  • Source
    USFDA