Z-1212-2014 Class I Terminated
FDA device recall Z-1212-2014 was initiated by Abbott Diabetes Care, Inc. on February 19, 2014 and is designated Class I. Reason for recall: 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 err… The recall status is terminated (terminated August 11, 2015). Affected quantity: 25,203 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2014
- Initiation Date
- February 19, 2014
- Termination Date
- August 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,203 units
Product Description
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,
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
Code Information
Catalog Number 17002 NDC 99073-0170-02. All serial numbers