bioMerieux, Inc. VITEK 2 Gram Negative Susceptibility Cards that contain the combination antibiotic Piperacillin/Tazobactam are being recalled by the Food and Drug Administration (FDA) because they are reporting incorrect results for testing the susceptibility of E. coli and K. pneumoniae. Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.

The cards are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK System. The affected cards were manufactured after March 10, 2009. Clinical laboratories have been notified to perform an alternative method of testing prior to reporting results for Piperacillin/Tazobactam and Escherichia coli results and Piperacillin/Tazobactam and Klebsiella pneumoniae with resistant results.

There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam, or for falsely-resistant K. pneumoniae results. bioMerieux is working closely with the FDA to correct the problem.

Any side effects or quality problems with this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch. Consumers with questions should contact their physicians. Healthcare professionals can get more information about the recall by contacting bioMerieux at 800-682-2666, Option 3.