Siemens Healthcare Diagnostics, Tarrytown, NY, 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.
An internal investigation has confirmed an increase in false susceptible and false intermediate misreads for imipenem and/or meropenem when read rapidly (< 16 hours) on the MicroScan® WalkAway Microbiology System. The investigation determined that no other antimicrobial agent results are affected. Siemens has notified the FDA of this action.
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 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. Dried Overnight Gram Negative Panels are not impacted by the issue.
The following panels have been affected by this issue (click here).
All affected customers have already been notified and instructed, via letter and the addition of Important Product Information (IPI) labeling to the panel boxes, to suppress all Susceptible (S) or Intermediate (I) interpretation and MIC results for imipenem and meropenem with all Synergies plus Negative and rapID/S plus Negative panels, until further notice.
Siemens Healthcare Diagnostics has also recommended that customers 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.
Customers with questions can contact Siemens Healthcare Diagnostics at (800) 677-7226, Option 1 (USA/Canada), Mondays through Fridays, 7 am to 7 pm (EST), and Saturdays, Sundays, and holidays 7:30 am to 4 pm (EST).
[Source: Siemens Healthcare Diagnostics]
