FDA-Device2020-06-03Class II
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
The Binding Site Group, Ltd.
Hazard
Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
Sold states
US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
Affected count
478 kits
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2020Don't want to check this manually?
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