Device recall
Z-1016-2010: Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model…
FDA device recall · Class II · Biogenex Laboratories
Key facts
| Recall number (Z-number) | Z-1016-2010 |
|---|---|
| Recall event | 51296 |
| Product | Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018… |
| Product code | KEY |
| Recalling firm | Biogenex Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2010 |
| FEI number | 2936532 |
At a glance
- None 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