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
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
Comment