Drug recall
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for…
FDA recall event 88064 · Class II · The Binding Site Group, Ltd.
Key facts
| Event ID | 88064 |
|---|---|
| Recall numbers | Z-2030-2021 |
| Recalling firm | The Binding Site Group, Ltd. |
| Product type | Devices |
| Products | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| Initiation date | May 20, 2021 |
| Report date | Jul 14, 2021 |
| Termination date | Feb 4, 2025 |
| 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: