epoc BGEM BUN Test Card — Class II medical device recall Z-1684-2025
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2025-05-07, distributed nationwide. The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sen
| Recall number | Z-1684-2025 |
|---|---|
| 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 | 2025-03-19 |
| Classified | 2025-04-29 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, DE, EC, EE, ES, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, KW, LK, LT, MA, MX, MY, NG, NL, NZ, OM, PE, PH, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 264,252 units |
| UPC / GTIN / UDI-DI | 00809708121860 |
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; 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 for recall
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
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-1684-2025. 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.