Events

Device Recall Pointe Scientific G6PD Screening Controls 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pointe Scientific, 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
    71988
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2487-2015
  • 사례 시작날짜
    2015-05-19
  • 사례 출판 날짜
    2015-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139536
  • 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
    Glucose-6-phosphate dehydrogenase (erythrocytic), screening - Product Code JBF
  • 원인
    A reduction in the reconstituted stability has been identified. clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. for this reason we suggest discontinuing use of the control set.
  • 조치
    The firm, POINTE SCIENTIFIC, issued a "TECHNICAL BULLETIN" on 5/19/2015, notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, and actions to be taken. The customers were instructed to: discontinue use of the control set and to incorporate this bulletin into your Quality Control files. The firm noted that this product has been placed on indefinite back-order and a replacement product is not currently available. For questions contact Pointe Scientific's Technical Service Department at 1-800-757-5313.

Device

Device Recall Pointe Scientific G6PD Screening Controls
  • 모델명 / 제조번호(시리얼번호)
    Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
  • 제품 설명
    Pointe Scientific G6PD Controls || Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). || Also sold as individual vials || Bottle: Clear glass vials || Cap: Rubber seal with colored aluminum seals || Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

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