Events

Device Recall Access Thyroglobulin Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    71878
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2733-2015
  • 사례 시작날짜
    2015-07-28
  • 사례 출판 날짜
    2015-09-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139264
  • 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,test,thyroglobulin - Product Code MSW
  • 원인
    Beckman coulter, inc. is recalling access thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/ml.
  • 조치
    On 07/28/2015 the firm sent out customer notification letters via first class mail and e-mail. The firm's letter contained the following instructions: 1. Discard all Access Thyroglobulin reagent pack lots listed in the letter. 2. Evaluate Access Thyroglobulin results <10 ng/mL when using the reagent pack lot numbers listed to determine if controls and/or patients were higher than expected or did not match the clinical status of the patient. 3. At the discretion of the Laboratory Director, notify clinicians that it is possible the Access Thyroglobulin sample results reported by the laboratory were affected by this issue. The firm's notification letter requests that the information be shared with laboratory staff. If any affected products have been forwarded provide a copy of the letter to them. The firm requests that customers complete and return the Response Form within 10 days. Any questions contact the Customer Care Center: 1. From website at http://www.beckmancoulter.com 2. By phone: call 1-800-854-3633 in the United States and Canada. 3. Outside the United States and Canada, contact local Beckman Coulter representative

Device

Device Recall Access Thyroglobulin Assay
  • 모델명 / 제조번호(시리얼번호)
    Catalogue number: 33860 Lot numbers: 431990 434727 430969 522896 523251  Expiration date: 10/31/16 12/31/16 08/31/16 04/30/17 05/31/17
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Morocco, New Zealand, Oman, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam and Yemen.
  • 제품 설명
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA