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.
FDA Recall Z-1245-2013 · Posted 2013-05-09
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Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2013-04-15
Date Terminated2015-08-03
Product Quantity335,273 meters; 209,336 remain at firm.
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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