RecallRadar

FDA Device recall Z-0684-2020

Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

On 2019-12-25 the FDA classified a Class II recall of Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 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

AgencyFDA Device
Recall numberZ-0684-2020
ClassificationClass II
Statusterminated
Initiated2016-12-02
Published2019-12-25
Last updated2026-09-13 11:55 UTC
CompanyPolymer Technology Systems
DistributionAR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, PR, RI, TN, UT, VA, WA

Product

Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

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_infoLot Numbers: 1606405 1610622 1610910

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-0684-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.