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FDA Recall Safety Alert: Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

Posted in Recalls

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA)

These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for microbial infection, and according to another FDA safety alert for Siemens MicroScan panels published September 4th, “using the MicroScan WalkAway System” may lead to a “false susceptible” reading or “false intermediate results for imipenem and meropenem antimicrobial susceptibility”. (emphasis added)

“This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.”

These panels use new, innovative technology and are generally considered effective for determining a patient’s susceptibility to infection by some bacteria, but not others.  In 2002, medical researchers Caroline M. O’Hara and J. Michael Miller of the Centers for Disease Control and Prevention (Epidemiology and Laboratory Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia) published a paper titled  “Ability of the MicroScan Rapid Gram-Negative ID Type 3 Panel To Identify Nonenteric Glucose-Fermenting and Nonfermenting Gram-Negative Bacilli” in which they write, “With an accuracy approaching 75%, this product may be used for the identification of the commonly isolated non-Enterobacteriaceae bacteria but may present problems in identification of other non-glucose-fermenting gram-negative bacilli.”

If you were recently tested for a microbial infection by one of these bacteria, consider asking your doctor if he or she used a Siemens MicroScan Synergies plus® or MicroScan® rapID/S plus Negative Panels kit.  Using antibiotics when you don’t need them can compromise your immune system, which could be just as dangerous as a false negative reading or the use of the wrong antibiotic drug.