epoc BGEM BUN Test Card [25pk] — Class II medical device recall Z-2272-2025
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2025-08-13, distributed nationwide. Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card
| Recall number | Z-2272-2025 |
|---|---|
| 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 | 2025-07-07 |
| Classified | 2025-08-05 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BH, BO, BR, CA, CH, CL, DE, DK, EC, EE, ES, FR, GB, GR, GT, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KR, LT, MA, MX, MY, NL, PH, PL, PT, PY, QA, RO, SE, SI, SK, TH, TR, TW, UA, UY, ZA |
| Quantity | 37,554 units |
| UPC / GTIN / UDI-DI | 00809708121860 |
| Lot numbers | 02-25095-30, 02-25096-30, 02-25096-40, 02-25096-50, 02-25097-40, 02-25098-30, 02-25098-40, 02-25098-50, 02-25099-30, 02-25099-40, 02-25099-50, 02-25099-70, 02-25100-30, 02-25100-50, 02-25101-30, 02-25101-40, 02-25101-70, 02-25102-30, 02-25102-40, 02-25102-50, 02-25103-30, 02-25103-50, 02-25104-70, 02-25105-30, 02-25105-40, 02-25105-50, 02-25105-70, 02-25106-40, 02-25107-50, 02-25107-70, 02-25108-50, 02-25108-70, 02-25110-70, 02-25111-30, 02-25111-50, 02-25111-70, 02-25112-30, 02-25112-50, 02-25112-60, 02-25112-70 and 41 more |
Product
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Reason for recall
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 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.
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-2272-2025. 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.