Events

Safety Alert for ARCHITECT CA 19-9 REAGENTS - Registration 80146501355 - Model ARCHITECT CA19-9XR - Lots Affected: 08849M500, 08851M500, 08852M500, 08853M500, 10122M500, 10040M500.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA.

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
    1147
  • Date
    2012-06-28
  • 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
    Abbott confirmed that six batches of the ARCHITECT CA19-9XR reagent show a change in the reported results for patients, and it was found that Abbott controls did not detect this change and presented results within the range. All other batches of reagents are not affected by this change. An internal investigation is under way. Initial indications suggest that the problem is caused by a component of the conjugate. All batches identified below have in common the same component of the conjugate. The investigation and collection of the impacted units in the client are in progress, and the forecast for completion is 09/15/2012. Anvisa follows this action.
  • Reason
    There may be a change in the reported results for patients, without abbott controls detecting this change.
  • Action
    Customers who received batches impacted by this change were notified via an Abbott statement to suspend their use immediately. Abbott will replace the affected products.

Device

ARCHITECT CA 19-9 REAGENTS - Registration 80146501355 - Model ARCHITECT CA19-9XR - Lots Affected:...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA