Recall Z-0682-2020— Polymer Technology Systems

Name: FDA recall Z-0682-2020
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: A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058. 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

A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

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.