Drug recall
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
FDA recall event 63617 · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 63617 |
|---|---|
| Recall numbers | Z-0696-2013 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be… |
| Initiation date | Nov 19, 2012 |
| Report date | Jan 30, 2013 |
| Termination date | Jan 13, 2014 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
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: