In September 2003, the U.S. Food and Drug Administration 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.
See your doctor if you have suffered injuries due to the VIDAS Chlamydia Assay. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Medical Devices & Implants