Recall Z-0686-2020— Polymer Technology Systems

Name: FDA recall Z-0686-2020
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: 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..

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

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.

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