—#98448

Product

VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K080107
Affected lot / code info: All lot numbers

Why it was recalled

The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

BioMerieux sent an Urgent Product Correction Notice (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786," letter dated March 30, 2011, via Fed EX on April 4, 2011. to all affected customers. The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Tazobactam (TZP2). The new cards will begin shipping by July 16, 2011, but in the meantime, the cards currently in possession of the customers can be used with specific required actions that need to be followed. Until the TZP redevelopment is completed and a resolution can be implemented, BioMerieux requires their customers to immediately take the following actions: The customers will be required to suppress the TZP2 resistant and susceptible results for Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, and Salmonella enterica and use an alternate method of testing. In addition, the customer is to suppress the TZP2 resistant result only for Klebsiella pneumonia and use an alternate method of testing. The letter provides instructions for configuring the VITEK 2 software to suppress the results from reporting. The instructions contained in the recall notification are to be applied to all current and future product lots that contain TZP2 until further notice. The customer is to complete the enclosed acknowledgement form and return it via FAX to acknowledge receipt of the notification and is requested to file the correction notice with their VITEK 2 Systems permanent records according to their internal policy or procedure. For questions or additional information customers were instructed to call 1-800-682-2666, option 3. In addit

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042

Distribution

Distribution pattern: There was no U.S. distribution as the cards were for export only to Canada and Sweden.

Timeline

Recall initiated: 2011-04-04
Posted by FDA: 2011-04-27
Terminated: 2012-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98448. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.