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U.S. Department of Health and Human Services

Medical Devices

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VITEK GPS-107 Cards

Class I Recall
Date Recall
Initiated:
January 28, 2004
Product:
VITEK GPS-107 gram positive susceptibility cards, lot M83X, catalog #V4368
Use:
These cards are used with the VITEK System in clinical laboratories as a in-vitro test to determine patient’s susceptibility of various bacteria to antibiotic treatment.
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.
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.
  For additional information on this product recall, see nearby links.