Device product
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,
Z-1211-2014
Product summary
- Event
- Event 67472
- Status
- Terminated
- Classification
- Class I
- Quantity
- not provided. Device has not been shipped in the last 5 years.
- Official record key
device-enforcement:Z-1211-2014
Official wording
Reason: Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.
Code information: Part number CAT11001-0; all serial numbers
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.