Recall Z-0604-06 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; Part Number: 70672-01; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
| Date | Mar 15, 2006 (initiated Feb 17, 2006) |
| Status | Terminated |
| Reason | The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. There were no shipments to U.S. Government facilities or foreign or Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051802 | FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc., Aug 9, 2005 |