Reported Feb 26, 2020 · Terminated
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
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
Is this the product you have?
- OPTILITE IgM Kit
- REFNK012.OPT.A, IVD
- UDI05051700017565
- Lot codes and dates
- Lot # 422251
- Amount recalled
- 3294 kits
Where it was sold
Why it was recalled
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
This product could cause temporary or reversible health problems — stop using it.
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