Known Identifiers & Locations
FEI Numbers
3002803444
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0042-06 |
FreeStyle FLASH Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Reason: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
|
2005-06-07 |
Terminated
|
View Details
|
| Z-0043-06 |
Tracker Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Reason: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
|
2005-06-07 |
Terminated
|
View Details
|
| Z-0044-06 |
Xceed Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Reason: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
|
2005-06-07 |
Terminated
|
View Details
|
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