Events

Device Recall Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alere San Diego, 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
    68469
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1928-2014
  • 사례 시작날짜
    2014-05-30
  • 사례 출판 날짜
    2014-06-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127976
  • 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
    Test,natriuretic peptide - Product Code NBC
  • 원인
    Alere san diego is recalling alere triage bnp calibrators for the beckman coulter access family of immunoassay systems because the bottle labeled as calibrator level 5 actually contains calibrator level 4. this results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected level 5 calibrator.
  • 조치
    Alere sent an Urgent Medical Device Recall letter dated May 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The primary consignees were instructed to block all stock of the affected lot in their warehouses; discontinue use and return all stock on hand, complete the provided verification form to document receipt of the notice and quantity to be returned, contact their primary consignees and advise them of the required discontinuation and return of the affected lot. For customers (or their sub-distributors) who have inventory on hand, Alere San Diego, Inc. will provide replacement product to the customer for the quantity of units that they must return. Customers are instructed to complete the attached reply form with the amount of unused product that will be returned for replacement. Customers with questions are instructed to contact Alere San Diego at 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8287, triage.support@alere.com

Device

Device Recall Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay ...
  • 모델명 / 제조번호(시리얼번호)
    Lot #328163
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide and the countries of Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
  • 제품 설명
    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 || The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • 제조사 주소
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA