Events

Device Recall Abbott Clinical Chemistry Alkaline Phosphatase Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories, 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
    59862
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3278-2011
  • 사례 시작날짜
    2011-08-26
  • 사례 출판 날짜
    2011-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103884
  • 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
    Nitrophenylphosphate, alkaline phosphatase or isoenzymes - Product Code CJE
  • 원인
    The reagent has the potential to be contaminated with mold, the cladosporium fungal species.
  • 조치
    The firm decided to recall and notified consignees by a Product Recall - Immediate Action Required letter on 08/26/11. The letter identified the affected product, the reason for the recall, the patient impact, and necessary actions to be taken by the customer. Customers are to determine if they are using or have the affected product in their inventory. Customers are to discontinue use and destroy any remaining product of the specified lots in accordance with their facility's policies and procedures. Alternative lots of the product should be ordered and the enclosed Customer Reply form should be completed and returned. The letter also states that customers may want to decontaminate their systems by following the steps in Attachment A. If the product from the affected lots were further distributed, a copy of the letter should be provided to those customers as well. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service.

Device

Device Recall Abbott Clinical Chemistry Alkaline Phosphatase Assay
  • 모델명 / 제조번호(시리얼번호)
    71628UN10, Exp. 11/19/2011; 62474UN10, Exp. 11/19/2011; and 08145UN11, Exp. 2/15/2012.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. || Used for the quantitation of alkaline phosphatase in human serum or plasma.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • 제조사 주소
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • 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