medical Class II Updated 2020-09-23

Siemens Healthcare Diagnostics Inc recalls Siemens epoc BGEM Test Card-In vitro diagnostic device for t

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 01-20095-10
View official government recall

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