Recall Z-0684-2020— Polymer Technology Systems

Name: FDA recall Z-0684-2020
Creator: U.S. Food and Drug Administration
Published: 2016-12-02

Class II · Terminated

Class II FDA medical device recall by Polymer Technology Systems, initiated 2016-12-02, terminated 2020-07-16. It names one FDA 510(k) clearance: K090413. 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..

Recalling firm: Polymer Technology Systems
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Terminated: 2020-07-16
Firm location: Whitestown, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K090413 — A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECBayer Healthcare, LLC·cleared 2009-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.