Device recall
Z-1051-04: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C…
FDA device recall · Class III · Bayer Healthcare LLC
Key facts
| Recall number (Z-number) | Z-1051-04 |
|---|---|
| Recall event | 29444 |
| Product | Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed). |
| Product code | KQO |
| Recalling firm | Bayer Healthcare LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 14, 2004 |
| 510(k) numbers | K960546 |
| FEI number | 1810909 |
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