Drug recall
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes…
FDA recall event 95018 · Class II · Beckman Coulter Mishima K.K.
Key facts
| Event ID | 95018 |
|---|---|
| Recall numbers | Z-2691-2024 |
| Recalling firm | Beckman Coulter Mishima K.K. |
| Product type | Devices |
| Products | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC)… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error… |
| Initiation date | Jul 10, 2024 |
| Report date | Aug 28, 2024 |
| City | Sunto-Gun |
| Country | Japan |
| FEI number | 3002807663 |
At a glance
- 1–9 Products in this recall
- None 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: