Device recall
Z-1044-2009: ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog…
FDA device recall · Class III · Immuno Concepts Inc
Key facts
| Recall number (Z-number) | Z-1044-2009 |
|---|---|
| Recall event | 50518 |
| Product | ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of… |
| Product code | DHN |
| Recalling firm | Immuno Concepts Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 10, 2009 |
| 510(k) numbers | K803276, K833148 |
| FEI number | 2918768 |
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