Siemens epoc BGEM Test Card-In vitro diagnostic device for the… — Class II medical device recall Z-2970-2020
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2020-09-23, distributed nationwide. Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for
| Recall number | Z-2970-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2020-08-28 |
| Classified | 2020-09-14 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | 01-20095-10 |
| Model numbers | 10736382 |
Product
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
Reason for recall
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
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-2970-2020. 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.