Device recall
Z-0938-2026: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
FDA device recall · Class III · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-0938-2026 |
|---|---|
| Recall event | 98019 |
| Product | HemosIL SynthAFax. Partial Thromboplastin Time Tests. |
| Product code | GFO |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K955638 |
| FEI number | 1217183 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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