Reported Dec 1, 2021 · Terminated
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the…
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?
- Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
- Lot codes and dates
- Model NumberLK018
- S UDI Code05051700006477
- Lot Number472776
- Model NumberLK018.10S
- UDI Code05051700012201
- Lot Number472664
- Amount recalled
- 2,254 kits
Where it was sold
Why it was recalled
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
This product could cause temporary or reversible health problems — stop using it.
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