Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinize

Recalled July 20, 2022 · FDA recall Z-1372-2022 · Siemens Healthcare Diagnostics

Hazard

Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. · FDA Class II

Units

263 Boxes

Sold at

AL CA CO FL IA ID KS NM OK TX

Description

Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

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

Manufacturer(s)

Siemens Healthcare Diagnostics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →