Medical Device Safety and Recalls: Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels - May Produce Incorrect Results

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels - May Produce Incorrect Results

A recall has been issued for Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels.  Incorrect test results may occur for the following antibiotics: Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. The test may report certain bacteria as sensitive to one of these antibiotics when the bacteria are actually resistant. Using these recalled devices may cause ineffective patient treatment, and in rare instances may contribute to death. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm425249.htm

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