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.