Events

URIC ACID / UIC ACID, List No. 7D76, Lot Number 95015HWOO. Registration number: 10055310819 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott-Divisão Diagnósticos 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    791
  • 날짜
    2004-04-12
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    A falsely elevated Uric Acid result may cause unnecessary treatment. There is no impact to the user's health or ability to use the product if the instructions guidelines. Increasing Uric Acid results can be identified with quality assay samples every 24 hours using the current quality control recommendations contained in the Uric Acid Reagent Application Sheet for the AEROSET Equipment. If the values ​​of the controls are high, the patient's results between the time of the high quality control test and the previous quality control test with acceptable result should be reviewed. If you have any further questions or concerns, please contact the Abbott Customer Service Center - Diagnostics Division - Phone 0800 119099
  • 원인
    When a uric acid cartridge, lot number 95015hw00 is placed in the apparatus and calibrated, samples and / or qc material can be raised to 1.1 mg / dl (0.07 moi / l) in a 24 hour period between the control trials. not all cartridges within this batch have been affected.
  • 조치
    Customer Letter was distributed to all customers who received lot number 95015HW00, recommending discontinuing the use of this lot number. This corrective action was implemented in March 2004. It is important that the following actions be taken: • Identify whether you are using or have in stock the AEROSET Uric Acid Reagents product, lot number 95015HW00. Discontinue use of batch number 95015HWOO, segregate kits from affected batches, and wait for collection of this material, by Abbott Laboratories. Will Abbott Laboratories provide replacement product for all Uric Acid kits destroyed from lot number 95015HWOO. Please complete the Response Protocol and return it to Abbott as instructed. Follow your laboratory procedures to verify the accuracy of test results and to communicate with health care providers for whom you provide services. Keep this release in the permanent archive of your laboratory. ¿If you have sent AEROSET Uric Acid Reagents, lot number 95015HW00 to another laboratory, please provide a copy of this notice to this one. During the investigation of the cause of this occurrence, it is recommended as a precautionary measure that the frequency of quality control monitoring for Uric Acid from two levels of controls (normal and abnormal) be increased every 24 hours for each 8 hours.

Device

URIC ACID / UIC ACID, List No. 7D76, Lot Number 95015HWOO. Registration number: 10055310819

Manufacturer

Abbott-Divisão Diagnósticos
  • Source
    ANVSANVISA