Drug recall
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer…
FDA recall event 70558 · Class II · Dako North America Inc.
Key facts
| Event ID | 70558 |
|---|---|
| Recall numbers | Z-1261-2015 |
| Recalling firm | Dako North America Inc. |
| Product type | Devices |
| Products | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the… |
| Initiation date | Feb 12, 2015 |
| Report date | Mar 18, 2015 |
| Termination date | Feb 11, 2016 |
| City | Carpinteria |
| State | CA |
| Country | United States |
| FEI number | 2022180 |
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: