CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

ReliOn FastA1C Test recalled by Polymer Technology Systems

Polymer Technology Systems is recalling ReliOn FastA1C Test, distributed in 18 states. The recall was initiated on 2 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

Quantity recalled20,825

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0685-2020
FDA event ID: 84231
Recalling firm: Polymer Technology Systems, Whitestown, IN
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2016
FDA classified: 13 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

2 Dec 2016	Recall initiated by company
13 Dec 2019	Classified by FDA	+1106 days
25 Dec 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

Where it was distributed

The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.

Arkansas California Florida Illinois Indiana Kentucky Minnesota North Carolina New Jersey New York Ohio Pennsylvania Puerto Rico Rhode Island Tennessee Utah Virginia Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 84231

This product is part of a recall event; the main page for the event is A1CNow Self Check (European) recalled by Polymer Technology Systems.

Reported	Class	Recall	Company	Reason	Where
25 Dec 2019	CLASS II	A1CNow Self Check (European) recalled by Polymer Technology Systems	Polymer Technology Systems	Device Malfunction	18 states
25 Dec 2019	CLASS II	CVS Health At Home A1C Test Kit recalled by Polymer Technology Systems	Polymer Technology Systems	Device Malfunction	18 states
25 Dec 2019	CLASS II	A1CNow+ Systems (professional use product) recalled	Polymer Technology Systems	Device Malfunction	18 states
25 Dec 2019	CLASS II	Walgreens At-Home A1C Test Kit recalled by Polymer Technology Systems	Polymer Technology Systems	Device Malfunction	18 states

More recalls from Polymer Technology Systems

All 21

Reported	Class	Recall	Company	Reason	Where
30 Oct 2024Device	CLASS II	A1CNow+ Multi-Test HbA1c System consists recalled	Polymer Technology Systems	Labeling Errors	Nationwide
21 Sep 2022Device	CLASS III	PTS Panels CHOL+GLU Test Strips recalled by Polymer Technology Systems	Polymer Technology Systems	Packaging Defects	Nationwide
11 Mar 2020Device	CLASS II	PTS Detect Cotinine recalled by Polymer Technology Systems	Polymer Technology Systems	Other	Nationwide
29 Jan 2020Device	CLASS II	Henry Schein CardioChek Plus Professional Analyzer recalled	Polymer Technology Systems	Device Malfunction	Nationwide
29 Jan 2020Device	CLASS II	PTS Diagnostics CardioChek Plus Professional Analyzer recalled	Polymer Technology Systems	Device Malfunction	Nationwide

Other Medical Software recalls

All 908

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide