Polymer Technology Systems recalls ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
- Recall date
- December 2, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0685-2020
- 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
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Get recall alerts
Free email alert whenever Polymer Technology Systems has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Polymer Technology Systems