FDA-Device2020-09-23Class II
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
Siemens Healthcare Diagnostics Inc
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.
Sold states
Nationwide Foreign: Canada
Affected count
463 boxes (50 test cards/box )
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2970-2020Don't want to check this manually?
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