Device recall
Z-0223-2025: A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable…
FDA device recall · Class II · Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0223-2025 |
|---|---|
| Recall event | 95416 |
| 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… |
| Product code | LCP |
| Recalling firm | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K090413 |
| FEI number | 3002698769 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database