Recall archive / FDA device enforcement
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparini... — FDA record Z-1372-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 263 Boxes
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1372-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AL CA CO FL IA ID KS NM OK TX
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 20, 2022
- Recall initiation date
- Jun 1, 2022
- Center classification date
- Jul 12, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.