Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health
horizonal rule

Medical Device Recalls
Class 1 Recall: VITEK GPS-107 Cards
See Related Information
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)
nancy.weaver@na.biomerieux.com (email)
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:

Office of In-Vitro Diagnostic Device Evaluation and Safety (OIVD) letter to the firm at: http://www.fda.gov/cdrh/oivd/letters/031904-bioMerieux.html.

FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00841.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".

Updated April 19, 2004

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH