Abbott Diabetes Care, Inc.

Part number/Lot or Serial Number/Expiration dates: 70345-02, 70468-1/0803221/Feb 2010; 70468-05/0802523/Jan 2010; 70344-02/0802832, 0802823, 0802422/JAN 2010, 70827-01/0817617/Jun 2010; 70468-04/0718730/ July 2009; 70817-01/0812304/May 2010

Clinical Chemistry and Clinical Toxicology Devices

2

No

The firm, ADC, quarantined the eight lots and disposed them to scrap. These eight lots were not released from the firm ADC's control; therefore, the firm was unable to determine the number of consignees.

FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA. || Product is used with FreeStyle and FreeStyle Lite Blood Glucose Meters to measure glucose (sugar) in whole blood. The test strips are used for testing outside the body (in vitro diagnostic use). The FreeStyle Blood Glucose Monitoring Systems are intended for use in the home and in professional settings to monitor blood glucose levels.

Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.

Clinical Chemistry and Clinical Toxicology Devices

3

No

US Distribution to states of NY and AZ.

Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. || The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.

Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Product was distributed worldwide.

Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.

Catalog Number 17002 NDC 99073-0170-02. All serial numbers

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.

FreeStyle Flash Blood Glucose Monitors System. || Meter made in China; || Distributed by TheraSense, Alameda, CA || The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. || Intended to monitor blood glucose from samples taken from the body. IVD use only,

Part number CAT11001-0; all serial numbers

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.

FreeStyle Blood Glucose Monitors System. || For in vitro diagnostic use only. Store at room || temperature below 86 degrees F (30 degrees C). Use test strips || only within the system operating temperature || range as outlined in your Owner's Booklet. || Meter made in China; || Distributed by Abbott Diabetes Care, Alameda, CA || The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. || The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. || Intended to monitor blood glucose from samples taken from the body. IVD use only,