Device recall
Z-0245-2007: VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0245-2007 |
|---|---|
| Recall event | 36512 |
| Product | VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume… |
| Product code | CHI |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 22, 2008 |
| 510(k) numbers | K845027 |
| FEI number | 1000136573 |
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