Device Recall FreeStyle Flash

All lot numbers beginning with R and all lot numbers T-G158-62981 and below are included.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.

FreeStyle FLASH Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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,