Polymer Technology Systems recalls A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 30…

Recall date

December 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0682-2020

FDA classification

Class II

Brand / firm

Polymer Technology Systems

Sold / distributed

The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058