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Old 09-18-2008, 02:38 PM
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Default Diabetes Related Recalls

Abbott FreeStyle Strips Recall

http://www.fda.gov/bbs/topics/ENFORC.../ENF01073.html

PRODUCT

Abbott Free Style Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter, Recall # Z-1813-2008

CODE

Part numbers/Serial numbers/Exp. Date: CAT12050-01/0618625/Jul08; M70449-03/0703325/Feb09; CAT12450-01 (70345-02)/0618129/Jun08; CAT70450-01/0700815/Jan09; CAT70447-02/0628646/Oct08; CAT12450-01 (70345-02)/0627030/Sep08; CAT70450-02/0703019/Jan09; CAT12050-02/0703118/Jan09; CAT12050-03/0715129/May09

RECALLING FIRM/MANUFACTURER

Abbott Diabetes Care, Inc., Alameda, CA, by letters, visits or telephone on April 24, 2008. Firm initiated recall is ongoing.

REASON

Flaws in strip voltage continuity may result in frequency of an Error 3 (“Er3”) message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.

VOLUME OF PRODUCT IN COMMERCE

2,954,900 strips

DISTRIBUTION

Nationwide and Internationally