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U.S. Department of Health and Human Services

Safety

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VITEK GPS-107 (gram positive susceptibility cards)

Audience: Clinical laboratory specialists and healthcare professionals

[March 26, 2004] bioMerieux, Inc. of Hazelwood, Missouri issued a Class I recall of VITEK GPS-107 gram positive susceptibility cards, lot M83X, catalog #V4368. 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. Some of the GPS-107 cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. Use of the defective cards may pose a risk of potentially life threatening consequences due to inaccurate test results. (Updated 4/1/2004 to provide correct lot number.)

[UPDATE May 14, 2004] bioMerieux expanded its recall to include an additional lot, B28E.

[April 20, 2004 - Recall Notice - FDA]
[January 28, 2004 - Recall Notice - FDA]