Device recall
Z-0202-2016: VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0202-2016 |
|---|---|
| Recall event | 72289 |
| Product | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the… |
| Product code | JIT |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 22, 2018 |
| 510(k) numbers | K081543 |
| 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