# FDA recall Z-0686-2020

> **Polymer Technology Systems** · Class II · device recall initiated 2016-12-02.

## Product

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

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0686-2020
- **Recalling firm:** Polymer Technology Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-12-02
- **Report date:** 2019-12-25
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Whitestown, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0686-2020

## Citation

> AI Analytics. FDA recall Z-0686-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0686-2020. Source: US FDA. Licensed CC0.

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