Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its ARCHITECT Active-B12 Reagent kit. The affected devices are identified as follows:-
The manufacturer has identified a lot specific stability issue with both reagent lots 10533UP00 and 10534UP00. As the reagent ages, Relative Light Unit (RLU) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. Controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges.
There is a potential for falsely elevated Active-B12 results to be generated when using ARCHITECT Active-B12 reagent lots 10533UP00 and 10534UP00. Internal studies have determined the worst case magnitude of elevation to be up to 30% for Active-B12 concentrations close to 20 pmol/L and up to 20% for concentrations close to 30 pmol/L.
Affected users are instructed to discontinue use and immediately destroy any remaining inventory of ARCHITECT Active-B12 reagent lots 10533UP00 and 10534UP00 and order replacement material. They should also review the information with their Medical Director to determine if a review of results previously generated with reagent lots 10533UP00 and 10534UP00 is required.
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 2 December 2016