Important Safety Alerts

Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its Campylosel agar [Reference number: 43361; Lot number: 1004948090, 1004981930 and 1005023880].

Based on a lack of selectivity issue reported on plates of the impacted lots of Campylosel agar, the manufacturer initiated a complaint investigation to confirm product performance and determine root cause. While the investigation is still ongoing, the following have been identified:

• There is growth of a Enterobacter cloacae strain isolated in a laboratory on the impacted lots of Campylosel agar that could mask the growth of the Campylobacter strain. This growth could lead to a misinterpretation of the results and therefore to a false negative result.
• The growth of this Enterobacter cloacae strain on the impacted lots of Campylosel agar could be explained by higher MIC for aztreonam and cefoperazon antibiotics than usually.

According to the manufacturer, immediate corrective action was implemented on 5 Aug 2016 at the Manufacturing site level to optimize Campylosel agar manufacturing conditions by reducing the additive shelf-life when used for the manufacturing of Campylosel agar. The users are advised to follow the instructions and implemented the actions as indicated in Field Safety Notice

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 September 2016