bioMérieux, Inc. Recalls Two Lots of VIDAS® Chlamydia Assay

Date of Recall

2003-09-15

Recall Details

Durham, NC -September 15, 2003--bioMérieux, Inc. announced on August 6, 2003, that it initiated a worldwide voluntary product recall of two lots, 040212-0 and 040218-0, of its VIDAS® Chlamydia (CHL) assay for the detection of Chlamydia trachomatis. Two thousand two hundred and four kits, 60 tests per kit, were distributed to clinical laboratories from June 4 to July 30, 2003.

bioMérieux, Inc. learned, through routine internal Quality Control testing, that the recalled lots contained a raw material that caused an accelerated degradation of the product performance. As a result, a positive or equivocal test result may be reported as negative. Based upon studies conducted at bioMérieux, the assay was producing valid results up to July 24, 2003. Patients receiving a negative test result with these test kits since July 24,
2003, should ask their physicians if they should be re-tested.

Clinical laboratories were notified by bioMérieux to discontinue use of the recalled test kits and to destroy any remaining product. The company also recommended re-testing of any negative test results obtained since July 24, 2003.

bioMérieux has implemented corrective actions. The company has produced new lots of the VIDAS Chlamydia Assay and has shipped them to our customers. bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is cooperating with the FDA regarding recall activities. 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.

VIDAS is a registered trademark of bioMérieux.

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