Events

Device Recall TEG Haemonetics System Level II Control 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Haemonetics 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
    70352
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1130-2015
  • 사례 시작날짜
    2015-01-26
  • 사례 출판 날짜
    2015-02-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133242
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • 원인
    Specific lots of level ii control kits produce high maximum amplitude (ma) results, which are outside of the manufacturer's expected quality control range for ma parameter.
  • 조치
    Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.

Device

Device Recall TEG Haemonetics System Level II Control
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: HMO 9200  HMO 9217  HMO 9226  HMO 9232  HMO 9276  HMO 9285  HMO 9292 Exp. Date 1/2017
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
  • 제품 설명
    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. || Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • 제조사 주소
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • 제조사 모회사 (2017)
    Haemonetics Corporation
  • Source
    USFDA