Device recall
Z-2201-2011: Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System…
FDA device recall · Class II · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-2201-2011 |
|---|---|
| Recall event | 56389 |
| Product | Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on… |
| Product code | LFX |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2011 |
| 510(k) numbers | K092353 |
| FEI number | 3008272466 |
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