Withdrawal of the Architect reaction vials manufactured by Abbott Laboratories, USA
06.03.2009
The representative of the manufacturer Abbott Laboratories of USA, Abbott Laboratories d.o.o. notified the Agency for Medicinal Products and Medical Devices about the withdrawal of certain series of the Architect reaction vials used in the ARCHITECT diagnostics systems for immunochemical assays based on chemiluminescence.
When using the specified series of the Architect reaction vials, a discharge of static electricity can occur, resulting in an inability to conduct the assay, and in some cases, in false increased values of the assay results.
The representative notified all users not to use the reaction vials carrying specified serial numbers and initiated the procedure for withdrawal of the product from the market.
