A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the mon...
FDA Device Recall #Z-0223-2025 — Class II — September 18, 2024
Recall Summary
| Recall Number | Z-0223-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 18, 2024 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. |
| Location | Whitestown, IN |
| Product Type | Devices |
| Quantity | 2,452 units |
Product Description
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
Reason for Recall
The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
Lot / Code Information
UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019
Other Recalls from Polymer Technology Systems, Inc. dba ...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1741-2022 | Class III | PTS Panels CHOL+GLU Test Strips (REF 1765) | Aug 16, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.