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Siemens Healthcare Diagnostics Inc recalls Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anti
Recalled September 23, 2020 · FDA recall Z-2970-2020 · Siemens Healthcare Diagnostics
Hazard
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia. · FDA Class II
Units
463 boxes (50 test cards/box )
Sold at
Nationwide Foreign: Canada
Description
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
Product
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
Manufacturer(s)
Siemens Healthcare Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →