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.

Recall Number Z-1245-2013

Classification Class I

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

Product Distributed Qty 335,273 meters in the US, and 607,137 internationally

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.

Event Id 64876

Product Type Devices

Status Ongoing

Recalling Firm Abbott Diabetes Care, Inc., Alameda, CA, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-15

Initial Firm Notification of Consignee or Public Press Release

Distribution Pattern Nationwide Distribution