Drug recall
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
FDA recall event 94787 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 94787 |
|---|---|
| Recall numbers | Z-2428-2024 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal |
| Initiation date | May 27, 2024 |
| Report date | Jul 31, 2024 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
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: