Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its MicroScan Gram Negative panels with Amoxicillin/ K Clavulanate (Aug) and Ampicillin/Sulbactam (A/S). The affected devices are identified as the following:

• MicroScan panels with Amoxicillin/K Clavulanate (Aug) [Part Number: B1016-142, B1016-153, B1016-155, B1016-156, B1016-159, B1016-162, B1016-176, B1016-177, B1016-191, B1016-192, B1016-193, B1016-194, B1016-195]
• MicroScan panels with Ampicillin/Sulbactam (A/S) [Part Number: B1016-158, B1016-178, B1016-179, B1016-188]
• MicroScan panels with Amoxicillin/K Clavulanate (Aug) and Ampicillin/Sulbactam (A/S) [Part Number: B1016-163, B1016-175]

The manufacturer, as a result of an internal investigation, reported that the MicroScan panels listed above are reporting European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints using Clinical Laboratory Standards Institute (CLSI) dilution scheme for Aug and A/S.According to the manufacturer, the issue is not panel lot specific.

Affected users of MicroScan Panel types with Aug:

• There is a possibility to obtain false susceptible results for clinical isolates when applying EUCAST breakpoints on MicroScan panels with Aug.
• False susceptible results may lead to potential progression of infection or failure to control a bacterial infection leading to other complications.

Affected users of MicroScan Panels types with A/S:

• There is no safety impact on MicroScan panels with A/S.
• Applying EUCAST breakpoints to CLSI dilution scheme does not change category agreement errors for A/S because the susceptible dilution scheme for both CLSI and EUCAST are the same (8 mg/L /4 mg/L).

The manufacturer has updated the Dried Gram Negative Procedural Manual.

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 28 May 2021