Reported Jun 3, 2020 · Terminated
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four…
The Binding Site Group, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Binding Site Group, Ltd. · 8 Calthorpe Road · Birmingham, N/A · N/A
Is this the product you have?
- Optilite Optilite Rheumatoid Factor Kit
- RefLK151.OPT.A, IVD, Rx Only
- UDI05051700020015 (kit ea. containing four components)
- Lot codes and dates
- Kit Lot Number428224
- Amount recalled
- 478 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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