Reported Jul 14, 2021 · Terminated
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas…
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 Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems
- REFLK016.CB, IVD CE
- UDI05051700012096
- Lot codes and dates
- Lot Numbers487719/
- Exp
31-Jul-2022480133/
- Exp30-Sep-2022
- Lot 457890/ Exp30-Sep-2022
Where it was sold
Why it was recalled
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
This product could cause temporary or reversible health problems — stop using it.
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