Recall Z-0605-06 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Abbott Diabetes Care, Inc.
FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; Part Number: CAT70676-01
| 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
| K013147 | GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE Bionostics, Inc., Oct 24, 2001 |