Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results
Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (delayed diagnosis or unnecessary treatment) due to inaccurate diagnostic results, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 463 boxes of Siemens epoc BGEM Test Cards, model number 10736382. These in vitro diagnostic devices are used for the quantitative testing of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in laboratory or point-of-care settings. The recall affects Lot Number 01-20095-10, which was distributed nationwide and in Canada.
The recall was initiated because the test cards produced sporadically inconsistent discrepant (low bias) glucose results. This defect creates a potential for a delay in the diagnosis of hyperglycemia or the administration of unnecessary treatment for hypoglycemia.
Consumers and healthcare providers should stop using the affected test cards immediately. Users should check their inventory for the specific lot number and model number listed in this notice. If the product is found, it should be returned to the distributor or the manufacturer for credit or replacement.
The recalled product
- 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
- Siemens Healthcare Diagnostics Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 01-20095-10
Distribution
Distributed nationwide across the United States.
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