Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-2970-2020

August 28, 2020

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 86378
Status
Terminated
Classification
Class II
Quantity
463 boxes (50 test cards/box )
Official record key
device-enforcement:Z-2970-2020

Official wording

Reason: 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.

Code information: Lot Number: 01-20095-10

Distribution pattern: Nationwide Foreign: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.