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U.S. Department of Health and Human Services

Medical Devices

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VIDAS Chlamydia Assay

Class I Recall
Date Recall
Initiated:
August 6, 2003
Product:
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use, Product No. 30101; Lots 040212-0 and 040218-0.
Use:
This in-vitro diagnostic product is used in the laboratory on specimens collected from either symptomatic or asymptomatic patients for the qualitative detection of Chlamydia infections. It is used for analysis of female endocervical swabs and male uretha and urine specimens.
Recalling Firm:
bioMerieux
100 Rodolphe Street, Building 1300
Durham, N.C. 27712
Reason for Recall:
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.
Public Contact:
Anita M. McClernon, MS, RAC
Regulatory Affairs Specialist
919-620-2288
FDA District:
New England
FDA Comment:
Continued use of the defective assay could result in a moderate to high risk of serious adverse health consequences or death.