Device recall
Z-1136-2021: VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to…
FDA device recall · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1136-2021 |
|---|---|
| Recall event | 87200 |
| Product | VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays. |
| Product code | DIP |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2022 |
| FEI number | 1000136573 |
At a glance
- None 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