Drug recall
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the…
FDA recall event 71267 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 71267 |
|---|---|
| Recall numbers | Z-1713-2015 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range. |
| Initiation date | May 11, 2015 |
| Report date | Jun 10, 2015 |
| Termination date | Sep 12, 2017 |
| 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
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: