medical Class II Updated 2019-12-25

Polymer Technology Systems recalls ReliOn FastA1C Test, Software Version Revision D, REF Number

Recalled Product

ReliOn FastA1C Test, Software Version Revision D, REF Number 3055


Hazard / Issue

A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.

Issued by

FDA

Affected States: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI, TN, UT, VA, WA
Lot/Code Info: Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163
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