Device recall
Z-0685-06: Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab…
FDA device recall · Class II · Bayer Healthcare, LLC (Diagnostics Division)
Key facts
| Recall number (Z-number) | Z-0685-06 |
|---|---|
| Recall event | 34505 |
| Product | Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system. |
| Product code | CHL |
| Recalling firm | Bayer Healthcare, LLC (Diagnostics Division) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2012 |
| 510(k) numbers | K031560 |
| FEI number | 2432235 |
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