Z-2970-2020 Class II Terminated
FDA device recall Z-2970-2020 was initiated by Siemens Healthcare Diagnostics Inc on August 28, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 9, 2021). Affected quantity: 463 boxes (50 test cards/box ).
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 28, 2020
- Termination Date
- September 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 463 boxes (50 test cards/box )
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.
Distribution Pattern
Nationwide Foreign: Canada
Code Information
Lot Number: 01-20095-10