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Class I Medical Device Recall: bioMérieux, Inc., VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/T

Posted May 03 2011 12:00am

Recall Class: Class I

Date Recall Initiated: March 10, 2011

Product: bioMérieux, Inc., VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZPBlack circle with a 2 inside)

  • AST-N183, REF 411 021
  • AST-N184, REF 411 154
These products were manufactured and distributed from September, 2010 through April, 2011. The two products under the expanded recall were distributed in foreign countries only. The current scope of the expanded recall includes 114 additional products from the original recall in 2010.

See related Class I Recall notice .

This recall affects all future lots. Additional lots will be manufactured and distributed in the U.S. and foreign countries over the next four (4) months until Piperacillin/Tazobactam is removed from the cards by July, 2011.

Use: These cards are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® 2 System.

Recalling Firm:

bioMérieux, Inc.
595 Anglum Rd
Hazelwood, Missouri 63042

Reason for Recall: The Piperacillin/Tazobactam antibiotic on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli and seven additional organisms, Pseudomonas aeruginosa, Salmonella enterica, Providencia stuartii, Providencia rettgeri, Proteus vulgaris, Proteus mirabilis, and Morganella morganii. The same antibiotic is providing false resistant results for Klebsiella pneumoniae.

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.

Public Contact:

  • 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.

FDA District: Kansas

FDA Comments:

On April 4, 2011, the company sent its customers a notice entitled, "Urgent Product Correction Notice VITEK 2 Piperacillin/Tazobactam Test," informing its customers of the reason for the recall and includes the expansion of the additional organism. Customers are to perform the following two actions when using Piperacillin/Tazobactam (TZPBlack circle with a 2 inside) in testing.

  1. Use an alternative method for testing and reporting of Piperacillin/Tazobactam susceptibility for Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Salmonella enterica, E.coli and Klebsiella pneumoniae with resistant Piperacillin/Tazobactam results; and
  2. Configure the VITEK 2 software to suppress TZPBlack circle with a 2 inside results from reporting.

The instructions contained in the recall notice are to be applied to all current and future product lots that contain TZPBlack circle with a 2 inside until further notice.

The company asks that customers complete the acknowledgement form that was included in the letter and FAX it to acknowledge receipt of the notice.

In addition to the notice, a multi-language insert will go into boxes of future shipments to the customers that remind them of the actions they must take regarding TZPBlack circle with a 2 inside. The recall notification will accompany all shipments of instrument software kits for new customers.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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