Device product
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,
Z-1212-2014
Product summary
- Event
- Event 67472
- Status
- Terminated
- Classification
- Class I
- Quantity
- 25,203 units
- Official record key
device-enforcement:Z-1212-2014
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: Catalog Number 17002 NDC 99073-0170-02. 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.