Siemens Healthcare Diagnostics Inc Recall 90432
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
Siemens Healthcare Diagnostics Inc Recall 90432 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1372-2022 |
| Event ID | 90432 |
| Event 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 |
| Product Type | Devices |
| Distribution | AL CA CO FL IA ID KS NM OK TX |
| Quantity | 263 Boxes |
| Recall Reason | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. |
| Device Classification | 20220720 |
| Device Code Info | UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022 |
| Center Classification Date | 20220712 |
| Recall Initiation Date | 20220601 |
| Recalling Firm | Siemens Healthcare Diagnostics Inc |
| Initial Notification | Letter |
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