Events

Device Recall Cardiac Marker Test 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
    67910
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1540-2014
  • 사례 시작날짜
    2014-03-20
  • 사례 출판 날짜
    2014-05-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126592
  • 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
    These lots may not recover within range when tested using certain commercially available controls.
  • 조치
    Alere San Diego, Inc. initiated this recall by sending out notification letters via email and/or regular mail on March 20, 2014. The letter titled "URGENT MEDICAL DEVICE CORRECTION", dated "March 20, 2014, informed customers of the reason for recall, and potential impact, product description with lots numbers, customer/distributor required action, and contact information. The letter was accompanied by a "Customer/Distributor Verification Form". Customers were instructed that they may continue to use reagent lots 329599 and 331265. " If they are using an alternate commercial control with Reagent Pack Lots 329599 or 331265, they can receive the Alere Triage¿ BNP QC Controls PN 98201 by requesting them on the Verification Form. "Customers were instructed to share this information with their laboratory staff, including their laboratorys medical director and retain this notification as part of their laboratory Quality System documentation. For questions regarding this recall call 858-805-2000, ext 3015. " If they have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. " Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice. Only one Verification Form is required per facility. Customers with questions were instructed to call 877-308-8287 or email Triage.Support@alere.com.

Device

Device Recall Cardiac Marker Test
  • 모델명 / 제조번호(시리얼번호)
    Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS).  Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
  • 제품 설명
    Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.
  • 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