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Abbott Diabetes Care, Inc. recalls FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx
Recalled May 15, 2013 · FDA recall Z-1245-2013 · Abbott Diabetes Care
Hazard
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. · FDA Class I
Units
335,273 meters; 209,336 remain at firm.
Sold at
Nationwide Distribution
Description
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Product
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.
Manufacturer(s)
Abbott Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →