Events

Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Radiometer America 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
    51983
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1015-2010
  • 사례 시작날짜
    2009-03-26
  • 사례 출판 날짜
    2010-03-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81837
  • 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
    Analyzer, enzyme, for clinical use - Product Code CGL
  • 원인
    Analysis of customer data, (for abl 8x7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. these errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.
  • 조치
    The recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be placed in the Operators Manual to reflect this new information. The recall notification is also accompanied by an attached response FAX FORM which the customer is asked to complete and to fax back to Radiometer so as to acknowledge receipt of the recall notification letter and the revised insert. Please direct questions to the company TechLine at 1-800¿736¿0600 opt 2.

Device

Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 942-058, Article Number: D711
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.
  • 제품 설명
    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA