Siemens Recalls MicroScan Synergies Plus, RapID/S Plus Gram Negative Panels

(RTTNews) - Siemens Healthcare Diagnostics (SI) said it has issued a voluntary recall of its MicroScan Synergies plus® Negative and rapID/S plus Negative panels. These panels are used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria.

Siemens said an internal investigation has confirmed an increase in false susceptible and false intermediate misreads for imipenem and/or meropenem when read rapidly on the MicroScan® WalkAway Microbiology System¹. The investigation determined that no other antimicrobial agent results are affected. Siemens has notified the FDA of this action.

The company stated that this defect could potentially lead to misclassification of a resistant or partially resistant strain of gram negative bacteria which may result in treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.

As a result of these findings, Siemens said it has issued a voluntarily recall for MicroScan Synergies plus Negative and rapID/S plus Negative panels shipped from June 2011 through August 2013. This issue is not panel lot specific or related to a particular WalkAway instrument model.

All affected customers have already been notified and instructed, via letter and the addition of Important Product Information labeling to the panel boxes, 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, Siemens commented.