Drug recall
BD PCR Cartridges used with MAX System. Model Number: 437519
FDA recall event 95963 · Class II · Becton Dickinson & Co.
Key facts
| Event ID | 95963 |
|---|---|
| Recall numbers | Z-1004-2025 |
| Recalling firm | Becton Dickinson & Co. |
| Product type | Devices |
| Products | BD PCR Cartridges used with MAX System. Model Number: 437519 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for signal drift in specific lots of BD PCR Cartridges. |
| Initiation date | Dec 19, 2024 |
| Report date | Jan 29, 2025 |
| City | Sparks |
| State | MD |
| Country | United States |
| FEI number | 1119779 |
At a glance
- 1–9 Products in this recall
- 10–99 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: