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Polymer Technology Systems recalls ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Recalled December 25, 2019 · FDA recall Z-0685-2020 · Polymer Technology Systems
Hazard
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. · FDA Class II
Units
20,825
Sold at
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, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.
Description
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.
Product
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Manufacturer(s)
Polymer Technology Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →