Drug recall
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software…
FDA recall event 97788 · Class II · Abbott Laboratories
Key facts
| Event ID | 97788 |
|---|---|
| Recall numbers | Z-0489-2026 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. |
| Initiation date | Sep 18, 2025 |
| Report date | Nov 19, 2025 |
| City | Santa Clara |
| State | CA |
| Country | United States |
| FEI number | 2919069 |
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: