Medical device manufacturer, BD Diagnostic Systems, has issued a medical device safety alert concerning BBL Crystal Enteric/Nonfermenter ID Kit. The affected catalogue number is 245000 and the affected lot numbers are 2086315, 2101435, 2104316, 2129460, 2129487, 2163211, 2163213, and 2163215.
BD has determined through complaint investigation that the above referenced products have the citrate (CIT) and malonic acid (MLO) reagents in the reversed prong/well positions. This may lead to no-identification or multiple identification choices. Customers specifically reported split identification results between Citrobacter and Salmonella; however, other bacterial identifications requiring the use of these two substrates may also be affected.
According to the local supplier, the affected products have been distributed in Hong Kong. BD advised the affected customers to discontinue use of the affected lots and discard any remaining packages.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 December 2012