Device recall: A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 305
FDA enforcement event 84231 is a device recall by Polymer Technology Systems of Whitestown, IN, initiated 2 Dec 2016 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 16 Jul 2020. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Polymer Technology Systems.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Polymer Technology Systems, Whitestown, IN.
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."
Distribution
"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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0682-2020 | A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058 | 112,648 | Class II | Terminated | 25 Dec 2019 |
| Z-0683-2020 | A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 | 500 | Class II | Terminated | 25 Dec 2019 |
| Z-0684-2020 | Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 | 15,118 | Class II | Terminated | 25 Dec 2019 |
| Z-0685-2020 | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 | 20,825 | Class II | Terminated | 25 Dec 2019 |
| Z-0686-2020 | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 | 8285 | Class II | Terminated | 25 Dec 2019 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.