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

A1CNow+ Systems (professional use product) recalled

Polymer Technology Systems is recalling A1CNow+ Systems (professional use product), 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: Lot number 1618030 1630221 1630210 1606342 1624606 1611013 1627740 1618724 1624608 1625037 1611132 1619054 1627111 1619055 1619056 1624607 1618817 1602004 1630111 1619057 1627240 1611046 1611015 1618713 1630211 1611014 1618031 1625004 1619032 1627112 1625003 1624609 1618735 1606408 1611141 1625026 1610954 1611045 1606331 1703344 1611131 1602174 1630013 1618818 1627718 1602186 1618736 1611057 1619033 1610655 1625036 1602152 1610932 1606320 1610931 1610656 1618839 1610953 1611056 1624628 1619043 1610644 1618041 1618714 1624617 1606341 1606330 1618851 1618828 1619021 1610623 1606461 1610909 1624639 1611067 1611119 1618806 1606416 1619010 1606308 1611023 1610942 1606449 1610920 1606438 1610633 1611013 1627740 1618817 1703344 1602185 1610645 1700505 1627252 1630222 1625025 1618142 1611174 1627251 1618850 1606342 1619043 1606342 1606408 1703344 1619043 1606416 1611174 1619022 1606408 1611174 1619022

Quantity recalled112,648

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-0682-2020
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

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

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: Lot number 1618030 1630221 1630210 1606342 1624606 1611013 1627740 1618724 1624608 1625037 1611132 1619054 1627111 1619055 1619056 1624607 1618817 1602004 1630111 1619057 1627240 1611046 1611015 1618713 1630211 1611014 1618031 1625004 1619032 1627112 1625003 1624609 1618735 1606408 1611141 1625026 1610954 1611045 1606331 1703344 1611131 1602174 1630013 1618818 1627718 1602186 1618736 1611057 1619033 1610655 1625036 1602152 1610932 1606320 1610931 1610656 1618839 1610953 1611056 1624628 1619043 1610644 1618041 1618714 1624617 1606341 1606330 1618851 1618828 1619021 1610623 1606461 1610909 1624639 1611067 1611119 1618806 1606416 1619010 1606308 1611023 1610942 1606449 1610920 1606438 1610633 1611013 1627740 1618817 1703344 1602185 1610645 1700505 1627252 1630222 1625025 1618142 1611174 1627251 1618850 1606342 1619043 1606342 1606408 1703344 1619043 1606416 1611174 1619022 1606408 1611174 1619022

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	ReliOn FastA1C Test recalled by Polymer Technology Systems	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

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