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FDA > CDRH > Medical Device Recalls > Class I Recall - VITEK GPS-107 Cards

Medical Device Recalls
Class I Recall: VITEK GPS-107 Cards

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

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