Drug recall
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA recall event 84614 · Class II · Clinical Diagnostic Solutions, Inc.
Key facts
| Event ID | 84614 |
|---|---|
| Recall numbers | Z-1001-2020 |
| Recalling firm | Clinical Diagnostic Solutions, Inc. |
| Product type | Devices |
| Products | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle. |
| Initiation date | Jan 2, 2020 |
| Report date | Feb 12, 2020 |
| Termination date | Nov 3, 2022 |
| City | Plantation |
| State | FL |
| Country | United States |
| FEI number | 3002684533 |
At a glance
- 1–9 Products in this recall
- 1–9 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: