Device recall
Z-0608-05: Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0608-05 |
|---|---|
| Recall event | 30664 |
| Product | Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001. |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2005 |
| 510(k) numbers | K932642, K972673 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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