Recall Z-1372-2022 — 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
U.S. FDA — Device Enforcement · United States · 2022-06-01 · Class II
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Reported risk: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
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