Recall Z-1936-2009 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose lev
| Date | Sep 1, 2009 (initiated Jun 10, 2009) |
| Status | Terminated |
| Reason | Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters. |
| Root cause | Process control |
| Action | An "Important: Medical Device Notification" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400. |
| Quantity | 9,252 vials |
| Distribution | US only (states AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070850 | FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc., Apr 10, 2007 |