IMPORTANT: MEDICAL DEVICE NOTIFICATION
FreeStyle® and FreeStyle® Lite Blood Glucose Monitoring Test Strips

FreeStyle® Test Strip Lot Numbers 0803221, 0802523, 0802832, 0802823, 0802422 and 0718730 and FreeStyle® Lite Test Strip Lot Number 0817617 and 0812304

Recently, it has come to our attention that FreeStyle and FreeStyle Lite Test Strips from the eight (8) lot numbers mentioned above are being used by customers. These lots were not approved for distribution outside of Abbott Diabetes Care.

The six (6) FreeStyle Test Strip lots have the potential to generate an Error 3 ("Er3") message or fail to start a test while being used with a FreeStyle, FreeStyle Flash, FreeStyle Freedom or FreeStyle Navigator blood glucose meter and one (1) FreeStyle Lite Test Strip lot (lot 0812304) has the potential to generate the same error on FreeStyle Lite and FreeStyle Freedom Lite. Either situation will prevent the user from obtaining a blood glucose reading. Please know that any test results that have been received during prior tests while using these strips are accurate.

There is no evidence to suggest that the FreeStyle Lite test strip lot (lot 0817617) would cause an error or prevent the user from obtaining a blood glucose reading on a FreeStyle Lite or FreeStyle Freedom Lite blood glucose meter.

Please check the lot number on the test strip carton or vial to see if the strips are from one of the lot numbers mentioned above. Information is included on Page 2 of this letter that shows where to look for the test strip lot number. If the test strips are from an affected lot, please discontinue their use and call the Abbott Diabetes Care Customer Care line at: 1-800-310-1500. The ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent at no charge.

If you have any further questions, please call the Abbott Diabetes Care Customer Care line at 1-800-310-1500 so we can help you with your questions.

We sincerely apologize for any inconvenience this may cause and we thank you for your continued support of Abbott Diabetes Care and our FreeStyle and FreeStyle Lite blood glucose monitoring systems.

How To Tell If Your FreeStyle / FreeStyle Lite Test Strips Are Affected
Please check the lot number on your test strips. The lot number appears on the outside of the test strip box and on the label of the test strip vial.