epoc BGEM BUN Test Card — Class II medical device recall Z-0286-2025
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2024-11-13, distributed nationwide. Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGE
| Recall number | Z-0286-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2024-09-24 |
| Classified | 2024-11-01 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,292 units |
| UPC / GTIN / UDI-DI | 00809708121860 |
| Lot numbers | 08-24092-60, 08-24093-60, 08-24094-60, 08-24095-60, 08-24096-60 |
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Reason for recall
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0286-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.