CVS Health At Home A1C Test Kit — Class II medical device recall Z-0686-2020
Terminated recall by Polymer Technology Systems, reported 2019-12-25, distributed in AR, CA, FL, IL, IN, KY, MN, NC…. A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result
| Recall number | Z-0686-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Whitestown, IN, United States |
| Recall initiated | 2016-12-02 |
| Classified | 2019-12-13 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-07-16 |
| Distributed | AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, PR, RI, TN, UT, VA, WA |
| Countries outside the US | AE, AU, BD, BE, BH, BS, CA, CN, CZ, EG, ES, GB, GR, HK, HT, ID, IN, IT, JO, JP, KE, LB, MX, MY, NG, PH, PK, PL, SA, SE, SG, SI, TR, TT, UY, VN, ZA |
| Quantity | 8,285 |
| Reason classes | software |
| Lot numbers | 1606319, 1606405, 1606460, 1610622, 1610910, 1611163, 1618153 |
| Model numbers | 3059 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0686-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.