Z-1245-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- April 15, 2013
- Termination Date
- August 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 335,273 meters; 209,336 remain at firm.
Product Description
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Reason for Recall
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Distribution Pattern
Nationwide Distribution
Code Information
Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.