CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
CVS Health At Home A1C Test Kit recalled by Polymer Technology Systems
Polymer Technology Systems is recalling CVS Health At Home A1C Test Kit, distributed in 18 states. The recall was initiated on 2 Dec 2016 and the FDA has classified it as Class II.
Check your package
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-0686-2020
- 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
- Test Kits & Diagnostics
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
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
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.
ArkansasCaliforniaFloridaIllinoisIndianaKentuckyMinnesotaNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaPuerto RicoRhode IslandTennesseeUtahVirginiaWashington
Stores named: CVS
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 1618153
Where was it sold?
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.
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 84231This product is part of a recall event; the main page for the event is A1CNow Self Check (European) recalled by Polymer Technology Systems.
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|---|---|---|---|---|---|
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