The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels, manufactured by Siemens Healthcare Diagnostics, Inc. The affected products are identified as follows:-
MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System. This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. This recall covers 78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.
According to the FDA, the manufacturer has sent an urgent field safety notice dated 21 August 2013, to all affected customers. The letter identified the defective products, problem and actions to be taken and also instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. In addition, Siemens recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing.
For details, please visit the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367217.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm367163.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 September 2013