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
Reported: September 23, 2020 Initiated: August 28, 2020 #Z-2970-2020
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 463 boxes (50 test cards/box )
- Distribution
- Nationwide Foreign: Canada
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 463 boxes (50 test cards/box ).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2970-2020.
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