Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- April 24, 2008
- Posted
- September 11, 2008
- Terminated
- March 29, 2011
- Recall Number
- Z-1813-2008
- Quantity
- 2954900 strips
- Firm Location
- Alameda, CA
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.
Distribution
Class II Recall - Worldwide Distribution --- including USA and countries of Sweden, Norway, Netherlands, Luxembourg, Switzerland, Israel and Denmark.
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.