FDA Device recall Z-0686-2020
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 by Polymer Technology Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0686-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-02 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Polymer Technology Systems |
| Distribution | AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, PR, RI, TN, UT, VA, WA |
Product
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Reason
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.
Identifiers
| code_info | Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0686-2020%22
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