FDA Device recall Z-1713-2015
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System by Siemens Healthcare Diagnostics, citing discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1713-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-11 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | n/a |
Product
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.
Reason
Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
Identifiers
| code_info | 10454742 10454729 10461894 10470625 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1713-2015%22
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