FDA Device recall Z-1685-2025
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System by Siemens Healthcare Diagnostics, citing the occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1685-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-19 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Reason
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Identifiers
| code_info | Siemens Material Number (SMN): 10736382; Udi-DI: 00809708072254; Lot Numbers: All lot numbers with prefix (xx) 00 or 06…Siemens Material Number (SMN): 10736382; Udi-DI: 00809708072254; Lot Numbers: All lot numbers with prefix (xx) 00 or 06; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2025%22
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