Events

Cholestech LDX Lipid Controls 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biosite Inc Dba Innovacon 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
    56985
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0441-2011
  • 사례 시작날짜
    2010-10-06
  • 사례 출판 날짜
    2010-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95112
  • 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
    Multi-Analyte Controls - Product Code JJY
  • 원인
    The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
  • 조치
    All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010. Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. Consignees with questions about the information contained in the notification were instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877 441 7440 FAX: 858 805 8457 E-mail: Response.ts@alere.com

Device

Cholestech LDX Lipid Controls
  • 모델명 / 제조번호(시리얼번호)
    Lot # SV0146
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
  • 제품 설명
    Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. || Assayed quality control material for use with the Cholestech LDX System.
  • Manufacturer
    Biosite Inc Dba Innovacon Inc.

Manufacturer

Biosite Inc Dba Innovacon Inc.
  • 제조사 주소
    Biosite Inc Dba Innovacon Inc., 9975 Summers Ridge Rd, San Diego CA 92121
  • 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