Device recall
Z-0676-05: PolyTiter software version 2.8 for use in the Polymedco PolyTiter…
FDA device recall · Class III · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0676-05 |
|---|---|
| Recall event | 30934 |
| Product | PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624… |
| Product code | DHN |
| Recalling firm | Diasorin Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| 510(k) numbers | K822397 |
| FEI number | 2182595 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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