Recall Z-1245-2013 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the finge
| Date | May 9, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| Reason | AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. |
| Root cause | Software design |
| Action | Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instruct |
| Quantity | 335,273 meters; 209,336 remain at firm. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120568 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc., Mar 29, 2012 |