Device recall
Z-1084-2026: Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1084-2026 |
|---|---|
| Recall event | 98163 |
| Product | Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA. |
| Product code | LCO |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K003767 |
| FEI number | 2245451 |
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