Drug recall
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical…
FDA recall event 94728 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 94728 |
|---|---|
| Recall numbers | Z-2237-2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal… |
| Initiation date | Feb 29, 2024 |
| Report date | Jul 10, 2024 |
| City | Chaska |
| State | MN |
| Country | United States |
| FEI number | 2122870 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: