The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and moni…
- Recall date
- October 28, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1053-2017
- FDA classification
- Class II
- Brand / firm
- The Binding Site Group, Ltd.
- Sold / distributed
- Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Why it was recalled
A change in the calibration curve causing an increase in false prozone flags.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
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