Abbott Diabetes Care, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1245-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: April 15, 2013

Date Posted: May 15, 2013

Recall Number: Z-1245-2013

Event ID: 64876

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.

Status: Terminated

Product Quantity: 335,273 meters; 209,336 remain at firm.

Code Information:

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

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated