VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm na

FDA device recall Z-2050-2011 · posted 2011-04-27 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LON

Quantity affected

3,000 boxes as of 3/31/11

Distribution

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

Date initiated

2011-04-04

Date posted

2011-04-27

Date terminated

2012-06-01

Location

Hazelwood, MO

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