Device Recall Estrogen Receptor (SP1) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cell Marque Corporation 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
    77209
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2201-2017
  • 사례 시작날짜
    2017-05-05
  • 사례 출판 날짜
    2017-06-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-09-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Reagents,specific,analyte - Product Code MVU
  • 원인
    Cell marque has determined the need to issue a product recall after identifying product intended to be sold outside the u.S. was not properly labeled as "for export only" as required by section 801 (e )(1) of the fd&c; act.
  • 조치
    Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.

Device

  • 모델명 / 제조번호(시리얼번호)
    7.0 ml lot 1603506A , expiry 201 9-01;  lot 1422402D/1422402L, expiry 2017-07.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • 제품 설명
    Estrogen Receptor (SP1) || 7.0 mL Catalog number 249R-18; || Hematology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • 제조사 모회사 (2017)
  • Source
    USFDA