Drug recall
HIV-1 Grp O & M, HIV-2, HCV &/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT/pool testing)
FDA recall event 95911 · Class III · Roche Molecular Systems, Inc.
Key facts
| Event ID | 95911 |
|---|---|
| Recall numbers | B-0195-2025 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Product type | Biologics |
| Products | HIV-1 Grp O & M, HIV-2, HCV &/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT/pool testing) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Roche Molecular Systems, Inc. confirmed that the cobas MPX 480T US-IVD, Lot K16865 allowed the use of the kit on the cobas 6800/8800 for 23 runs instead of 20 runs as specified in the Instructions for… |
| Initiation date | Oct 7, 2024 |
| Report date | Mar 5, 2025 |
| Termination date | Jul 10, 2025 |
| City | Branchburg |
| State | NJ |
| Country | United States |
| FEI number | 2243471 |
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: