Events

Martel Printer Accessory to iSTAT Portable Clinical Analyzer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Point of Care 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
    51872
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2328-2009
  • 사례 시작날짜
    2009-04-22
  • 사례 출판 날짜
    2009-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81493
  • 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
    Glucose Test System - Product Code CGA
  • 원인
    It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
  • 조치
    Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.

Device

Martel Printer Accessory to iSTAT Portable Clinical Analyzer
  • 모델명 / 제조번호(시리얼번호)
    Printer i-STAT Catalog number 06723-91; battery pack catalog number 06F21-35. Martel Printers with serial numbers 281071578 to 281071977; 281174571 to 281174970; 281276302 to 281276701 and 290178290 to 290178689. Repaired printers received since November 4, 2008; Replacement chargeable battery packs received since October 30, 2008.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. || Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • 제조사 주소
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520
  • 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