bioMérieux, Inc. Issues Urgent Expanded Product Recall for VITEK® 2 Piperacillin/Tazobactam Test on Gram Negative Susc
Posted Apr 08 2011 3:34pm
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FOR IMMEDIATE RELEASE - April 8, 2011 - As a follow up to the communication issued on September 16, 2010, bioMérieux, Inc. is voluntarily expanding its worldwide product recall of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZP). These cards, 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 has provided instructions to its customers informing them that VITEK® 2 susceptibility testing results for TZP for the organisms listed above 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 prior to reporting susceptibility results. A subsequent internal investigation conducted by bioMérieux determined 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. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible results for Piperacillin/Tazobactam (TZP) and isolates of these specific organisms, or for falsely-resistant K.pneumoniae results.
Included below is a list of VITEK® 2 Gram Negative Susceptibility cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK® 2 Gram Negative Susceptibility cards created that contain TZP are affected by this product correction.
bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.
Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting 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.
Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2010, revenues reached €1.357 billion with 87% of sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479). Other information can be found at www.biomerieux.com.
List of all currently available test cards that contain TZP