Device recall
Z-2214-2014: VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2214-2014 |
|---|---|
| Recall event | 68840 |
| Product | VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the… |
| Product code | JIX |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2018 |
| 510(k) numbers | K072443 |
| FEI number | 1000305841 |
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