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Abbott Diabetes Care, the maker of the Freestyle Insulinx blood glucose meter, has initiated a voluntary Class I recall of this meter. A Class I is the most serious type of recall, involving a reasonable proba­bility that use of this product will cause serious adverse health conse­quences. These meters display and store in memory an incorrect blood sugar level result if you have an extremely high blood sugar level (1,024 mg/dL and above). This high of a blood glucose level is rare, but impor­tantly, is a serious health risk that requires immediate attention. The Freestyle Insulinx blood glucose meters were distributed from April 18, 2012 through April 1, 2013. If you have a Freestyle Insulinx blood glucose meter, the following options are available: 

• Access a software update to install on your meter to resolve the issue at: www.freestyleinsulinx.com/swupdate1. The software update will allow you to maintain settings and historical data on your meter.

• Contact Abbott Diabetes Care Customer Service at 1–866-723‑2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replace­ments are available, and Abbott will send a meter to you immedi­ately upon request.

For the full FDA report, click here