Events

AxSYM ß -HCG Total Reagents. Registration number: 10055310335 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios 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
    789
  • 날짜
    2004-08-24
  • 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
    Customers were notified through the Customer Letter accompanied by Response Protocol. While Abbott investigates the cause of this occurrence, all batches of AxSYM ß-hCG Total Reagents are being placed into an internal monitoring program. If you have any questions about the information contained in this release, please contact the Customer Service Center. 0800-119099.
  • 원인
    Possible cause of error 1048 (cal a / b ratio toa large). although the calibration curve of the assay with these batches is valid, patient outcomes may demonstrate an elevation when compared to other batches. it is not expected that this occurrence, change the results obtained as negative «5 mlu / ml) to positive (> 25 ml / ml).
  • 조치
    ¿The AxSYM Total ß-hCG assay is intended for early detection of pregnancy. Detection of very low levels of AxSYM Total ß-hCG is not a rule of no pregnancy. This is because the values ​​double approximately every 48 hours in a normal pregnancy. Patients with very low levels of ß-hCG should be re-collected and this sample should be retested after 48 hours. For diagnostic purposes, the results of hCG should be used in conjunction with other data; symptoms, results of other tests, clinical data, etc. Ectopic pregnancy can not be distinguished from normal pregnancy only by hCG assays. While investigations for lots 172020100 and 175560100 of AxSYM Total ß-hCG. not distributed in Brazil, are in progress, the Abbott Laboratories Division Diagnostics by precautionary measure, recommends the following procedure for all batches of AxSYM Total ß-hCG:. All samples should be initially processed without dilution, if the result is> 1000 mlU / mL, then the dilution protocol (1/10 and 1/200) may be used. The Abbott Laboratories Diagnostics Division is continually working to complete this investigation as soon as possible. We apologize for the inconvenience this has caused to your laboratory.

Device

AxSYM ß -HCG Total Reagents. Registration number: 10055310335

Manufacturer

Abbott Laboratórios Divisão Diagnósticos
  • Source
    ANVSANVISA