Polymer Technology Systems recalls CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

Recalled December 25, 2019 · FDA recall Z-0686-2020 · 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

8285

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

CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

Manufacturer(s)

Polymer Technology Systems

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →