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bioMérieux, Inc. Issues Urgent Product Correction for VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam
Tel: +1 919-620-2937
Tel: +1 919-620-2937
FOR IMMEDIATE RELEASE - October 27, 2010 - DURHAM, N.C. - bioMérieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZPv). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® System. Clinical laboratories were notified to perform an alternative method of testing prior to reporting results for:
- Piperacillin/Tazobactam (TZPvv) and Escherichia coli results
- Piperacillin/Tazobactam (TZPvv) and Klebsiella pneumoniae with resistant results
bioMérieux also provided instructions to implement suppression rules to prevent inappropriate reporting of results. Customers can continue to use the VITEK® 2 cards following the guidelines above.
An internal investigation by bioMérieux confirmed user reports that VITEK® 2 antimicrobial susceptibility testing may incorrectly report E. coli and K. pneumoniae susceptible isolates as resistant to Piperacillin/Tazobactam (TZPv). This same investigation also found that E. coli isolates resistant to Piperacillin/Tazobactam (TZPv) may be incorrectly identified as susceptible
Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam (TZPv), or for falsely-resistant K. pneumoniae results.
Attached below is a list of VITEK® 2 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 cards created that contain TZPv 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, 24 hours a day; 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.
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. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our 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. Other information can be found at www.biomerieux.com
VITEK® 2 TZPv Affected Cards