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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Polymer Technology Systems: 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.

Agency Publication Date: December 13, 2019
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Affected Products

Product: A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

Lot Numbers: Lot number 1618030 1630221 1630210 1606342 1624606 1611013 1627740 1618724 1624608 1625037 1611132 1619054 1627111 1619055 1619056 1624607 1618817 1602004 1630111 1619057 1627240 1611046 1611015 1618713 1630211 1611014 1618031 1625004 1619032 1627112 1625003 1624609 1618735 1606408 1611141 1625026 1610954 1611045 1606331 1703344 1611131 1602174 1630013 1618818 1627718 1602186 1618736 1611057 1619033 1610655 1625036 1602152 1610932 1606320 1610931 1610656 1618839 1610953 1611056 1624628 1619043 1610644 1618041 1618714 1624617 1606341 1606330 1618851 1618828 1619021 1610623 1606461 1610909 1624639 1611067 1611119 1618806 1606416 1619010 1606308 1611023 1610942 1606449 1610920 1606438 1610633 1611013 1627740 1618817 1703344 1602185 1610645 1700505 1627252 1630222 1625025 1618142 1611174 1627251 1618850 1606342 1619043 1606342 1606408 1703344 1619043 1606416 1611174 1619022 1606408 1611174 1619022

Lot Numbers:
Numbers
number
Product: A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

Lot Numbers: 1610622 1618153

Lot Numbers:
Numbers
Product: Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

Lot Numbers: 1606405 1610622 1610910

Lot Numbers:
Numbers
Product: ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

Lot Numbers:
Numbers
Product: CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84231
Status: Resolved
Manufacturer: Polymer Technology Systems
Manufactured In: United States
Units Affected: 5 products (112,648; 500; 15,118; 20,825; 8285)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.