[Posted 11/10/2010]

AUDIENCE: Risk Manager, Laboratory, Infectious Disease

ISSUE: bioMérieux, Inc. VITEK 2 Gram Negative Susceptibility Cards that contain Piperacillin/Tazobactam are reporting incorrect results for testing the susceptibility of E. coli and K. pneumoniae to this drug. For E. coli, both falsely-resistant and falsely-susceptible results have been reported; for K. pneumoniae, only falsely resistant results have been observed. Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.

BACKGROUND: These cards are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK System.

RECOMMENDATION: The company issued instructions to their customers to complete alternative test confirmations. See the Recall Notice for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/10/2010 - Recall Notice - FDA]