FDA-Device2022-07-20Class II
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
Hazard
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Sold states
AL CA CO FL IA ID KS NM OK TX
Affected count
263 Boxes
Manufactured in
2 Edgewater Dr, Norwood, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2022Don't want to check this manually?
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