Device recall
Z-1664-2023: VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50…
FDA device recall · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1664-2023 |
|---|---|
| Recall event | 92245 |
| Product | VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the… |
| Product code | DLJ |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2250051 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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