Recall of Vitek 2 Gram Negative Susceptibility Cards

Following up on its September 16, 2010 communication, bioMérieux, Inc. is expanding its global medical device recall of VITEK® 2 Gram Negative Susceptibility Cards, which contain the antibiotic Piperacillin/Tazobactam (TZP).

These cards, which were manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® 2 System. Clinical laboratories have been notified to perform an alternative method of testing prior to reporting results for:

•

Piperacillin/Tazobactam (TZP) and Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa and Salmonella enterica

• Piperacillin/Tazobactam (TZP) and Klebsiella pneumoniae with resistant results 


bioMérieux provided instructions to its customers informing them that VITEK® 2 susceptibility testing results for TZP for these organisms are potentially inaccurate and should not be reported.

An alternative method should be used for testing and reporting Piperacillin/Tazobactam susceptibility. Customers can continue to use the VITEK® 2 Gram Negative Susceptibility cards for other antibiotics and for TZP testing of Acinetobacter baumannii, Citrobacter koseri, Serratia marcescens, and Klebsiella pneumoniae with susceptible results.

The previous product correction notification (410874) informed users that, due to performance issues, users should test all E. coli strains (regardless of VITEK® 2 results), and Klebsiella pneumoniae with resistance by VITEK® 2 testing by an alternative method before reporting susceptibility results.

A subsequent internal investigation conducted by bioMérieux found that VITEK® 2 Gram Negative Susceptibility cards may also incorrectly determine M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P aeruginosa and S. enterica susceptibility such that susceptible isolates may be reported as resistant to Piperacillin/Tazobactam (TZP), and resistant isolates reported as susceptible to Piperacillin/Tazobactam (TZP). The current expanded recall is based on these findings.

This investigation also confirmed the previously identified performance issues with E. coli and K. pneumoniae testing.

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli, M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P. aeruginosa or S. enterica isolate. To date, there have been no reports of treatment failures linked to either falsely-resistant or -susceptible results for Piperacillin/Tazobactam (TZP) and isolates of these organisms, or for falsely-resistant K. pneumoniae results.

A listing of all available test cards containing TZP, globally and in the U.S., can be accessed on the FDA website at: http://www.fda.gov/Safety/Recalls/ucm250515.htm. Of these affected cards, all lot numbers in distribution and all future distributions, are affected until further notice; also, all new VITEK® 2 Gram Negative Susceptibility cards created that contain TZP are included.

Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux Customer Service at 1.800.682.2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm; or by fax at 1-800-FDA-0178.