epoc BGEM BUN Test Card with epoc Host SW v3 — Class II medical device recall Z-2476-2023
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2023-09-06, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. There is potential for discrepant high glucose results in samples with glucose results on the lower end of the
| Recall number | Z-2476-2023 |
|---|---|
| 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 | 2023-06-01 |
| Classified | 2023-08-28 |
| Reported by FDA | 2023-09-06 |
| Distributed | AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, TX |
| Countries outside the US | AE, CA, CN, CO, FI, IN, MX, NO, SE, VN |
| Quantity | 3,201 units |
| UPC / GTIN / UDI-DI | 00809708121860 |
| Lot numbers | 04-23003-60 |
| Expiration dates | 2023-05-20, 2023-06-20, 2023-07-21, 2023-08-15, 2023-08-25 |
Product
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Reason for recall
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
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-2476-2023. 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.