A1CNow+ Multi-Test HbA1c System consists of — Class II medical device recall Z-0223-2025
Completed recall by Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., reported 2024-10-30, distributed nationwide. The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer
| Recall number | Z-0223-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., Whitestown, IN, United States |
| Recall initiated | 2024-09-18 |
| Classified | 2024-10-24 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, ZA |
| Quantity | 2,452 units |
| UPC / GTIN / UDI-DI | 00381933021011 |
| Lot numbers | 2323019, 9331803 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0223-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.