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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 Recall
FreeStyle InsuLinx Blood Glucose Monitoring System
see related information
Date Posted May 09, 2013
Recall Status1 Open
Recall Number Z-1245-2013
Recall Event ID 64876
Premarket Notification
510(K) Number
K120568 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product FreeStyle 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, California 94502-7000
For Additional Information Contact Kelly 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
DESIGN: Software Design
Action Abbott 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 Commerce 335,273 meters; 209,336 remain at firm.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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