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U.S. Department of Health and Human Services

Class 1 Device Recall FreeStyle InsuLinx Blood Glucose Monitoring System

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 Class 1 Device Recall FreeStyle InsuLinx Blood Glucose Monitoring Systemsee related information
Date Initiated by FirmApril 15, 2013
Date PostedMay 09, 2013
Recall Status1 Terminated 3 on August 03, 2015
Recall NumberZ-1245-2013
Recall Event ID 64876
510(K)NumberK120568 
Product Classification System, test, blood glucose, over the counter - Product Code NBW
ProductFreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Code Information Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information ContactKelly Duffy
510-239-2775
Manufacturer Reason
for Recall		AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
FDA Determined
Cause 2		Software design
ActionAbbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.
Quantity in Commerce335,273 meters; 209,336 remain at firm.
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NBW
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