Device recall
Z-1225-03: Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1225-03 |
|---|---|
| Recall event | 27035 |
| Product | Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.] |
| Product code | CGA |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 24, 2003 |
| 510(k) numbers | K841503 |
| 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