Drug recall
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA recall event 86598 · Class II · Primus Corporation
Key facts
| Event ID | 86598 |
|---|---|
| Recall numbers | Z-0321-2021 |
| Recalling firm | Primus Corporation |
| Product type | Devices |
| Products | Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product did not receive pre-market approval or clearance. |
| Initiation date | Oct 9, 2020 |
| Report date | Nov 11, 2020 |
| Termination date | Nov 4, 2021 |
| City | Kansas City |
| State | MO |
| Country | United States |
| FEI number | 1931251 |
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: