Device recall
Z-0971-2012: VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0971-2012 |
|---|---|
| Recall event | 60794 |
| Product | VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600… |
| Product code | JIT |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2016 |
| 510(k) numbers | K042643 |
| 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