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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle

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  Class 2 Device Recall FreeStyle see related information
Date Initiated by Firm May 22, 2006
Date Posted August 03, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall Number Z-1306-06
Recall Event ID 35486
Product Classification Blood Glucose Meter - Product Code NBW
Product Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky.
Alameda, CA 94502.

Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
Code Information All codes.
Recalling Firm/
Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
Manufacturer Reason
for Recall
The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
FDA Determined
Cause 2
Action On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
Quantity in Commerce approx. 2,365,000 meters (both recall numbers)
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.