Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its MicroScan Gram Negative panels with Mecillinam. The details for the affected products are as follows:
According to the manufacturer on a recent study, Mecillinam did not meet performance claims for Enterobacterales when compared to the current recommended agar dilution reference method per the European Committee on Antimicrobial Susceptibility Testing (EUCAST) Clinical Interpretive Criteria V.11. This study showed false resistant and false susceptible results with the affected device, which may lead to unnecessary change in antimicrobial therapy and potential progression of infection, respectively.
The manufacturer advised that Mecillinam should no longer be reported with the products and a Dried Gram Negative Procedural Manual had been updated. Users can access the updated manual by visiting the manufacturer's website and follow the instructions for Mecillinam in section 'Limitation of the Procedure'.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 26 April 2021