Siemens epoc BGEM Test Card-In vitro diagnostic device recall
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or…
Why was Siemens epoc BGEM Test Card-In vitro diagnostic device 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 01-20095-10
- Product
- Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or…
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 463 boxes (50 test cards/box )
- Distribution
- Nationwide Foreign: Canada
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)