Drug recall
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for…
FDA recall event 86655 · Class II · Becton, Dickinson and Company, BD Biosciences
Key facts
| Event ID | 86655 |
|---|---|
| Recall numbers | Z-0562-2021 |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Product type | Devices |
| Products | BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. |
| Initiation date | Oct 5, 2020 |
| Report date | Dec 16, 2020 |
| Termination date | Mar 11, 2022 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 2916837 |
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: