The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0683-2020·Announced 2019-12-25

Polymer Technology Systems Recalls A1CNow SELF CHECK Software Bug

Polymer Technology Systems is recalling A1CNow SELF CHECK devices due to a software bug that may display incorrect numerical values instead of expected symbols.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the hazard is a software display error that does not explicitly report injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Polymer Technology Systems is recalling 500 units of A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062. 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.

The affected products were distributed to 18 US states and Puerto Rico, as well as 38 foreign countries. The specific lot numbers involved are 1610622 and 1618153.

Consumers should check their device model and software version to see if it is affected. If the device is part of this recall, users should contact Polymer Technology Systems for further instructions.

The recalled product

Product
A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Manufacturer
Polymer Technology Systems
Category
Medical Device — Diagnostic Equipment
Hazard
Affected units
500

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: 1610622 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 →

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