Medical device manufacturer, Abbott Laboratories, has issued a medical device safety alert concerning its Alere NT-proBNP for ARCHITECT Controls. The affected devices are identified as follow:
Abbot Laboratories becomes aware that the manufacturer of the Alere NT-proBNP for ARCHITECT Controls, Axis-Shield, has identified a stability issue that may lead to Quality Control values falling outside of expected ranges prior to assigned expiry date.
According to the manufacturer, a potential delay may exist in the reporting of patient results due to Quality Control values falling outside of expected ranges. Internal testing on patient samples showed no atypical bias for the impacted lots, therefore if Quality Controls are in range, patient results are not impacted.
If affected users have an alternate control lot available in inventory, they should immediately discontinue use of the affected control lot(s) and switch to the alternate control lot. They should also destroy any remaining inventory of impacted material according to their laboratory procedures.
If the affected users do not have an alternate control lot available in inventory and the current lot continues to generate valid QC results, they should immediately order a replacement control lot. They may continue to use the affected control lot(s) while following their current laboratory QC procedures. Once they receive the replacement control lot, they may destroy any remaining inventory of impacted material according to their laboratory procedures.
Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 4 September 2018