Drug recall
ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA recall event 90937 · Class II · Luminex Corporation
Key facts
| Event ID | 90937 |
|---|---|
| Recall numbers | Z-0134-2023 |
| Recalling firm | Luminex Corporation |
| Product type | Devices |
| Products | ARIES SARS-CoV-2 Assay, REF: 50-10047 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. |
| Initiation date | Sep 14, 2022 |
| Report date | Nov 2, 2022 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 3002524000 |
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: