Drug recall
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer…
FDA recall event 76690 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 76690 |
|---|---|
| Recall numbers | Z-1703-2017 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential… |
| Initiation date | Mar 3, 2017 |
| Report date | Apr 5, 2017 |
| Termination date | Jul 3, 2018 |
| City | Newark |
| State | DE |
| Country | United States |
| FEI number | 2517506 |
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: