epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing o...
FDA Device Recall #Z-1372-2022 — Class II — June 1, 2022
Recall Summary
| Recall Number | Z-1372-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 1, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics Inc |
| Location | Norwood, MA |
| Product Type | Devices |
| Quantity | 263 Boxes |
Product Description
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.
Distribution Pattern
AL CA CO FL IA ID KS NM OK TX
Lot / Code Information
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Other Recalls from Siemens Healthcare Diagnostics Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2272-2025 | Class II | epoc BGEM BUN Test Card [25pk]. Material Number... | Jul 7, 2025 |
| Z-2230-2025 | Class II | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 ... | Jun 26, 2025 |
| Z-1673-2025 | Class II | Stratus CS Acute Care cTNI TestPak.IVD test for... | Mar 31, 2025 |
| Z-1684-2025 | Class II | epoc BGEM BUN Test Card (25 pk) for the epoc Bl... | Mar 19, 2025 |
| Z-1685-2025 | Class II | epoc BGEM Crea Test Card (25 pk) for the epoc B... | Mar 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.