Alerta De Seguridad para ARCHITECT CA 19-9 REAGENTS - Registration 80146501355 - Model ARCHITECT CA19-9XR - Lots Affected: 08849M500, 08851M500, 08852M500, 08853M500, 10122M500, 10040M500.

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.

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.