Siemens Healthcare Diagnostics, a provider of clinical diagnostics and therapeutic systems, has voluntarily recalled its MicroScan Synergies plus negative and rapID/S plus negative panels, which are used to determine the antimicrobial susceptibility and/or identification for gram-negative bacteria.
The company has issued a voluntarily recall on the two panels shipped between June 2011 and August 2013 following an internal investigation that confirmed an increase in false susceptible and false intermediate misreads for imipenem and/or meropenem when read rapidly (WalkAway microbiology system).
The internal investigation also confirmed that no other antimicrobial agent results are affected.
This defect could lead to misclassification of a resistant or partially resistant strain of gram negative bacteria and may result in treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.
The company’s Dried Overnight gram negative panel does not have any impact by this issue.
Siemens has notified the US Food and Drug Administration on this action and also notified and instructed all affected customers to suppress all susceptible or intermediate interpretation and MIC results for imipenem and meropenem with all Synergies plus negative and rapID/S plus negative panels, until further notice.
The company has also recommended customers to consider reviewing previous Synergies plus negative and rapID/S plus negative test results from June 2011 through August 2013, conduct patient follow-up, and/or repeat imipenem and/or meropenem susceptibility testing by another product or method, if the isolates are still available.