epoc BGEM Test Card 25 Test Cards/box — Class II medical device recall Z-1372-2022
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2022-07-20, distributed in AL, CA, CO, FL, IA, ID, KS, NM…. Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary
| Recall number | Z-1372-2022 |
|---|---|
| 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 | 2022-06-01 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | AL, CA, CO, FL, IA, ID, KS, NM, OK, TX |
| Quantity | 263 boxes |
| UPC / GTIN / UDI-DI | 00809708121860 |
| Lot numbers | 11-22005-50 |
| Model numbers | 10736515 |
| Expiration dates | 2022-06-22 |
Product
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
Reason for recall
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
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-1372-2022. 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.