Drug recall
Alinity S System List Number 06P16-01
FDA recall event 93905 · Class III · Abbott Laboratories, Inc
Key facts
| Event ID | 93905 |
|---|---|
| Recall numbers | B-0310-2024 |
| Recalling firm | Abbott Laboratories, Inc |
| Product type | Biologics |
| Products | Alinity S System List Number 06P16-01 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Abbott has identified two potential issues that may be exhibited when operating the Alinity s System software version 2.8.2 (List Number 04U76-17) and prior. This issue only impacts Alinity s System… |
| Initiation date | Jan 16, 2024 |
| Report date | May 15, 2024 |
| Termination date | Aug 21, 2025 |
| City | Irving |
| State | TX |
| Country | United States |
| FEI number | 1628664 |
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: