Drug recall
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection…
FDA recall event 76050 · Class II · The Binding Site Group, Ltd.
Key facts
| Event ID | 76050 |
|---|---|
| Recall numbers | Z-1053-2017 |
| Recalling firm | The Binding Site Group, Ltd. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A change in the calibration curve causing an increase in false prozone flags. |
| Initiation date | Oct 28, 2016 |
| Report date | Jan 25, 2017 |
| Termination date | Jul 27, 2017 |
| City | Birmingham |
| Country | United Kingdom |
| FEI number | 3002808340 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: