U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

FDA > CDRH > Medical Device Recalls > Class I Recall - VIDAS Chlamydia Assay

Medical Device Recalls
Class I Recall: VIDAS Chlamydia Assay

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.
  For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2003/ENF00816.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".

Updated October 15, 2003

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH