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U.S. Department of Health and Human Services

Medical Devices

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VITEK GPS-107 Cards (Additional Lot)

Class I Recall

Date Recall
Initiated:
April 20, 2004
Product:
VITEK GPS-107 gram positive susceptibility cards, lot B28E, catalog #V4368. Lot M83X of this product was recalled in January 2004 for the same problem.
Use:
These cards are used with the VITEK System as a laboratory test to determine patient’s susceptibility of various bacteria to antibiotic treatment. The test result enables the physician to determine which antibiotic to treat the patient with.
Recalling Firm:
bioMerieux, Inc.
595 Anglum Road
Hazelwood, Missouri 63042-2320
Reason for Recall:
Some of the GPS-107 cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. This could cause both false resistance and false susceptible results to be reported if the laboratory did not notice the error when reviewing the test results.
Public Contact:
Nancy Weaver
Staff Regulatory Affairs Specialist
314-731-8695 (telephone)
314-731-8689 (fax)
FDA District:
Kansas
FDA Comment:
Use of the defective cards may pose a risk of potentially life threatening consequences due to inaccurate test results. Class I recalls are the most serious type of recall and involve situations where there is a
reasonable probability that use of the product will cause serious injury or death.
  For additional information on this product recall, see the press release from BioMerieux, Inc and the FDA Enforcement Report.