Reported Sep 23, 2020 · Terminated
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or…
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- 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
- Lot codes and dates
- Lot Number01-20095-10
- Amount recalled
- 463 boxes (50 test cards/box )
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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