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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

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 Detail

Event Id 64876
Product Type Devices
Status Ongoing
Recalling Firm Abbott Diabetes Care, Inc.
City Alameda
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-15
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide Distribution