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U.S. Department of Health and Human Services

Medical Devices

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Press Release from bioMerieux, Inc. Regarding Recall of a Lot of VITEK GPS-107 Cards

The following press release is from BioMérieux, Inc. relating to a Class I Medical Device Recall.


FOR IMMEDIATE RELEASE

Media Contact:

Becky Schneider
BioMérieux, Inc.
919-620-2353
Becky.Schneider@na.biomerieux.com

bioMérieux, Inc. Recalls a Lot of VITEK GPS-107 Cards


Durham, NC - May 11, 2004 - bioMérieux, Inc. announced on April 20, 2004, that it initiated a worldwide voluntary product recall of VITEK® catalog # V4368, GPS-107 Cards from lot B28E, a laboratory test for antimicrobial susceptibility. One thousand nine hundred and ninety boxes containing 20 cards per box, were distributed to clinical laboratories from February 24, 2004 to March 5, 2004. Lot M83X of this product was recalled for the same problem in January 2004.

A small percentage of the VITEK GPS-107 cards were stamped with an incomplete card code that causes the VITEK reader to read and report results for the GPS-107 cards as if they were VITEK GPS-105 cards. This could result in inaccurate antibiotic susceptibility test results being reported for 17 antibiotics if the laboratory did not notice the error when reviewing the test results. The potentially inaccurate results could be reported for staphylococci, enterococci, Group D streptococci and Streptococcus agalactiae. Inaccurate results could delay or deprive a patient from receiving the most appropriate antibiotic therapy.

Clinical laboratories that received this lot of cards were notified by bioMérieux to discontinue the use of the recalled cards and to destroy any remaining product. The company recommended that the laboratories review their results to determine if any results were reported from misread cards. If any incorrect reports were made the laboratory was directed to take immediate action in accordance with the facility’s policies and to ensure that all appropriate medical personnel were notified. There have been no reports of adverse events related to the potential misreporting of results.

bioMérieux has implemented corrective actions and provided replacement cards to our customers. bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is cooperating with the FDA regarding this Class I recall. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666. Physicians with questions on this recall should contact their clinical diagnostic laboratories. Consumers with questions about this recall should contact their physicians.

VITEK® is a registered trademark of bioMérieux.