MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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The FDA Center for Devices and Radiological Health posted a Class I recall notice for the VIDAS Chlamydia Assay, used in the laboratory on specimens collected from either symptomatic or asymptomatic patients for the qualitative detection of Chlamydia infections. The recalling firm is bioMerieux, Durham, N.C. A raw material, bovine serum albumin, contained in the VIDAS (CHL) reagent strip, is causing an accelerated degradation of the product's performance and creating the potential for false negative results to be reported. Continued use of the defective assay could result in a moderate to high risk of serious adverse health consequences or death.
Read the MedWatch 2003 safety summary, including links to the CDRH recall posting, at: http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#vidas