Polymer Technology Systems recalls A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

Recall date: December 2, 2016
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-0683-2020
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.

A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

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