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
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