Events

Safety Alert for AxSYM ß -HCG Total Reagents. Registration number: 10055310335

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios Divisão Diagnósticos.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    789
  • Date
    2004-08-24
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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).
  • Action
    ¿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