VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use
Audience: Clinical Microbiologists, Hospital Laboratory Staff and Risk Managers
The FDA Center for Devices and Radiological Health posted a Class I recall notice for this in-vitro diagnostic product, 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.
[Sept 26, 2003 - Recall Notice - FDA]