Drug recall
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
FDA recall event 68394 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 68394 |
|---|---|
| Recall numbers | Z-1944-2014 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual… |
| Initiation date | May 20, 2014 |
| Report date | Jul 9, 2014 |
| Termination date | Aug 10, 2015 |
| 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: