Device recall
Z-1901-2010: VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model…
FDA device recall · Class II · Bio-Rad Laboratories Inc
Key facts
| Recall number (Z-number) | Z-1901-2010 |
|---|---|
| Recall event | 51498 |
| Product | VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and determination of the relative percent… |
| Product code | LCP |
| Recalling firm | Bio-Rad Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2011 |
| 510(k) numbers | K984268 |
| FEI number | 2915274 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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