Device recall
Z-2237-2024: Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric…
FDA device recall · Class II · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-2237-2024 |
|---|---|
| Recall event | 94728 |
| Product | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog… |
| Product code | JJE |
| Recalling firm | Beckman Coulter, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2122870 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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