Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optilite Optilite Rheumatoid Factor Kit Recalled by The Binding Site Group, Ltd. Due to Assigned Rheumatoid Factor (RF) calibrator value for calibrator...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Quantity: 478 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 20 states: AL, AZ, AR, FL, GA, KY, MD, MA, MI, MN, MS, NE, NY, NC, OR, PA, TX, VT, WA, WI
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report