Class II — Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
| Recalling firm | POLYMER TECHNOLOGY SYSTEMS, INC. |
|---|---|
| Registered facility | Polymer Technology Systems (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | 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. |
| 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. |
| Quantity | 2,452 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan, South Africa. |
| Initiated | 2024-09-18 |
| Classified | 2024-10-24 |
| Recall number | Z-0223-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. (Z-0223-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95416/
Alerts for POLYMER TECHNOLOGY SYSTEMS, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.