Device recall
Z-1008-2012: S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1008-2012 |
|---|---|
| Recall event | 60929 |
| Product | S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters. |
| Product code | CGL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 17, 2014 |
| 510(k) numbers | K051968 |
| FEI number | 1523456 |
At a glance
- 1–9 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