Drug recall
Software version 4.44A utilized on the BD MAX System
FDA recall event 76900 · Class II · BD LIFE SCIENCES
Key facts
| Event ID | 76900 |
|---|---|
| Recall numbers | Z-1864-2017 |
| Recalling firm | BD LIFE SCIENCES |
| Product type | Devices |
| Products | Software version 4.44A utilized on the BD MAX System |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers… |
| Initiation date | Jul 29, 2015 |
| Report date | Apr 26, 2017 |
| Termination date | Apr 19, 2017 |
| City | Sparks Glencoe |
| State | MD |
| Country | United States |
| FEI number | 3013091131 |
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: