Drug recall
VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen), Product Code: 6912263
FDA recall event 94598 · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Event ID | 94598 |
|---|---|
| Recall numbers | B-0119-2025 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Product type | Biologics |
| Products | VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen), Product Code: 6912263 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | QuidelOrtho has confirmed an issue involving the performance of VITROS Immunodiagnostic Product HIV Combo Control (HIV p24 Antigen), not meeting the stability specifications up to 13 weeks as defined… |
| Initiation date | Apr 24, 2024 |
| Report date | Dec 18, 2024 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000136573 |
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: