Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 30...

FDA Device Recall #Z-0682-2020 — Class II — December 2, 2016

Recall Summary

Recall Number Z-0682-2020
Classification Class II — Moderate risk
Date Initiated December 2, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Polymer Technology Systems
Location Whitestown, IN
Product Type Devices
Quantity 112,648

Product Description

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

Reason for Recall

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.

Distribution Pattern

The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.

Lot / Code Information

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

Other Recalls from Polymer Technology Systems

Recall # Classification Product Date
Z-0683-2020 Class II A1CNow SELF CHECK (European), Software Version ... Dec 2, 2016
Z-0686-2020 Class II CVS Health At Home A1C Test Kit, Software Versi... Dec 2, 2016
Z-0685-2020 Class II ReliOn FastA1C Test, Software Version Revision ... Dec 2, 2016
Z-0684-2020 Class II Walgreens At-Home A1C Test Kit, Software Versio... Dec 2, 2016

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Polymer Technology Sys... Recalls by Firm Recall Reasons Device Safety Stats