FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Ro
FDA device recall Z-0605-06 · posted 2006-03-15 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
- Action taken
- On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 900
- Distribution
- The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product
- Date initiated
- 2006-02-17
- Date posted
- 2006-03-15
- Date terminated
- 2011-01-20
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE (K013147) | Bionostics, Inc. | 2001-10-24 |