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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Freestyle Blood Glucose Monitoring System Test STrips

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  Class 2 Device Recall Abbott Freestyle Blood Glucose Monitoring System Test STrips see related information
Date Initiated by Firm April 24, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on March 29, 2011
Recall Number Z-1813-2008
Recall Event ID 48090
510(K)Number K992684  
Product Classification Glucose test system - Product Code LFR
Product Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
Code Information 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.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information Contact
510-749-5400
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action Recall initiated on April 24, 2008. An Urgent Medical Device Correction was issued to customers. Consignees were notified, along with registered users of the FreeStyle Freedom meters, via recall letters, visits or phone calls. Distributors will be notified, along with the creation of customer lists and tracking of communications to sub-recall. If you have any questions call Tina Mazurkiewicz at 1-800-777-6565.
Quantity in Commerce 2954900 strips
Distribution Class II Recall - Worldwide Distribution --- including USA and countries of Sweden, Norway, Netherlands, Luxembourg, Switzerland, Israel and Denmark.
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.
510(K) Database 510(K)s with Product Code = LFR and Original Applicant = ABBOTT DIABETES CARE INC.
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