Drug recall
RegenKit-BCT Plus, Product Code: RK-BCT-2A
FDA recall event 92672 · Class III · Regen Lab Sa
Key facts
| Event ID | 92672 |
|---|---|
| Recall numbers | B-0606-2023, B-0607-2023, B-0608-2023 |
| Recalling firm | Regen Lab Sa |
| Product type | Biologics |
| Products | RegenKit-BCT Plus, Product Code: RK-BCT-2A, RegenKit-BCT/RegenPlasma, Product Code: RK-BCT-1, RegenKit-BCT/RegenPlasma, Product Code: RK-BCT-3 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | RegenLab USA LLC is recalling distributed RegenKit-BCT Family Kits (Product Codes: RK-BCT-1 (Batch number 085), RK-BCT-3 (Batch numbers 300 and 304) and RK-BCT-2A (Batch number 030)) because they may… |
| Initiation date | Jun 30, 2023 |
| Report date | Dec 13, 2023 |
| Termination date | Sep 23, 2024 |
| City | Le Mont-Sur-Lausanne |
| Country | Switzerland |
| FEI number | 3008496303 |
At a glance
- 1–9 Products in this recall
- 1–9 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: