Device 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
Z-1372-2022
Product summary
- Event
- Event 90432
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 263 Boxes
- Official record key
device-enforcement:Z-1372-2022
Official wording
Reason: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Code information: UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Distribution pattern: AL CA CO FL IA ID KS NM OK TX
Derived failure modes
-
Unknown
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.