Important Safety Alerts

Medical device manufacturer, Abbott Laboratories, has issued a medical device safety alert concerning its ARCHITECT Reaction Vessels [List Number: 7C15-03; Multiple Lot Numbers].

The manufacturer observed an increase in complaints due to static discharge in the ARCHITECT Reaction Vessel (RV) on the ARCHITECT i2000, i2000SR, and i1000SR at the optics reader. The static discharge can result in Error Code 1007 (Unable to process test, activated read failure) or potentially falsely elevated/positive results when using the ARCHITECT RV lots.

According to the manufacturer, static discharge impacts direct assays as the lower relative light unit (RLU) counts for direct assays could be impacted by the additional RLUs introduced by these static discharge spikes. There is potential impact to patient results if the static discharge occurs without generating an error code.

Affected users are instructed to take the following actions:-

• Determine if they have any of the affected lots in their inventory or in use on their analyzer.
• If they do not have any of these lots in their inventory or in use on their analyzer, no action is required.
• If they do have any remaining inventory of these lots or are unable to determine the lot number in use, immediately discontinue use and discard according to their laboratory procedures. Contact Customer Support to order replacement RVs.
• Review the medical safety alert notice with their medical director or laboratory management and follow their laboratory protocol regarding the need for reviewing previously reported patient results.

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 6 December 2019