The Recall Desk
ModerateFDA (Devices)·Z-0686-2020·Announced 2019-12-25

CVS Health At Home A1C Test Kit Recalled for Software Bug

Polymer Technology Systems is recalling CVS Health At Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a software display error that does not involve a physical defect or reported injuries, fitting the Moderate severity criteria for minor labeling or software errors.

Plain-English summary

Polymer Technology Systems is recalling the CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059. The recall involves 8,285 units distributed across 18 US states, Puerto Rico, and 38 foreign countries.

The recall is due to a software bug that may cause the device to display a numerical value less than 4% or greater than 13% instead of the expected <4% or >13% result. This error affects the display of extreme test results.

Consumers who have this product should stop using it and contact Polymer Technology Systems for instructions on how to proceed. The affected lot numbers are 1606319, 1606405, 1606460, 1610622, 1610910, 1611163, and 1618153.

The recalled product

Product
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Manufacturer
Polymer Technology Systems
Category
Medical Device — Home Diagnostic Test
Hazard
Affected units
8,285

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153

Distribution

Distributed in 18 states:

Part of a larger recall action

This product is one of 5 recalled by Polymer Technology Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Polymer Technology Systems

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Same hazard · software bug

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