Drug recall
Alinity m System, Part Number: 08N53-002
FDA recall event 94251 · Class II · Abbott Molecular, Inc.
Key facts
| Event ID | 94251 |
|---|---|
| Recall numbers | Z-1602-2024 |
| Recalling firm | Abbott Molecular, Inc. |
| Product type | Devices |
| Products | Alinity m System, Part Number: 08N53-002 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013… |
| Initiation date | Mar 20, 2024 |
| Report date | May 1, 2024 |
| City | Des Plaines |
| State | IL |
| Country | United States |
| FEI number | 3005248192 |
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: