Polymer Technology Systems recalls CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
- Recall date
- December 2, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0686-2020
- 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
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
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