Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its ARCHITECT STAT High Sensitive Troponin-I Assay.
The manufacturer is informing affected users of a product recall and reduced expiration dating for select ARCHITECT STAT High Sensitive Troponin-I Reagent lots. Predictive quality assurance monitoring of ARCHITECT STAT High Sensitive Troponin-I reagent lots was initiated following the field action that occurred in January (FA21JAN2016). As a result, the manufacturer has identified a potential for increased calibration failures prior to the expiration date.
According to the manufacturer, there is a potential for delay in results due to calibration errors and failure to calibrate. Nonetheless, there is no impact to generated patient results.
Manufacturer will continue to monitor performance of all on-market lots. Until root cause is determined and corrective actions are implemented, new reagent lots will have a proactively shortened expiration date of 4 months from date of manufacture. The expiration date will require adjustments to the laboratory inventory and order management practices.
Affected users are instructed either:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 May 2016