The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0684-2020·Announced 2019-12-25

Polymer Technology Systems Recalls Walgreens At-Home A1C Test Kits

Polymer Technology Systems is recalling 15,118 Walgreens At-Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

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, and the hazard involves a software bug causing incorrect display of extreme values without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Polymer Technology Systems is recalling 15,118 units of the Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056. The recall affects specific lot numbers: 1606405, 1610622, and 1610910.

The recall is being conducted because of 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 issue affects the accuracy of the test results for extreme values.

The affected products were distributed to various US states, including AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI, TN, UT, VA, and WA, as well as Puerto Rico. The products were also distributed to numerous foreign countries, including Australia, Canada, China, India, Japan, and Mexico. Consumers should stop using the affected test kits and contact the manufacturer for instructions on how to proceed.

The recalled product

Product
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Manufacturer
Polymer Technology Systems
Category
Medical Device — Home Diagnostic
Hazard
Affected units
15,118

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: 1606405 1610622 1610910

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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