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Recall Observatory FDA recall evidence

Device 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.

Z-1245-2013

April 15, 2013

Class I

Product summary

Firm
Abbott Diabetes Care, Inc.
Event
Event 64876
Status
Terminated
Classification
Class I
Quantity
335,273 meters; 209,336 remain at firm.
Official record key
device-enforcement:Z-1245-2013

Official wording

Reason: AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

Code information: Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.