The Recall Desk
ModerateFDA (Devices)·Z-0685-2020·Announced 2019-12-25

ReliOn FastA1C Test Recalled for Software Bug Affecting Result Display

Polymer Technology Systems is recalling ReliOn FastA1C Tests due to a software bug that may display incorrect numerical values instead of expected symbols.

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. The hazard is a software display error that does not involve a physical defect, contamination, or reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Polymer Technology Systems is recalling 20,825 units of the ReliOn FastA1C Test, Software Version Revision D, REF Number 3055. The recall involves specific lot numbers: 1606319, 1606405, 1606460, 1610622, 1610910, and 1611163.

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 the test outcome rather than the underlying measurement.

The affected products were distributed to 18 US states and Puerto Rico, as well as 38 foreign countries. Consumers should stop using the affected devices and contact the manufacturer for instructions on replacement or refund.

The recalled product

Product
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Manufacturer
Polymer Technology Systems
Category
Medical Device — Point-of-Care Testing
Hazard
Affected units
20,825

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

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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