Events

IMx Theophylline Reagent Pack In Vitro Test 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Diagnostic International, Ltd. 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
    37957
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0958-2007
  • 사례 시작날짜
    2007-04-11
  • 사례 출판 날짜
    2007-07-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52441
  • 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
    Theophylline Reagent - Product Code LER
  • 원인
    A decrease in mp values (calibration curve net polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: calibration error code 148 (polarization too small), calibration error code 172 (calibration not stored or calibration not accepted) controls out of range (when using a stored calibration curve).
  • 조치
    An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records

Device

IMx Theophylline Reagent Pack In Vitro Test
  • 모델명 / 제조번호(시리얼번호)
    Lot #41610Q100; Expiration date 04/25/2008
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore
  • 제품 설명
    IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. || This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer.
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • 제조사 주소
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA