FDA Device recall Z-2074-2020
Dako Autostainer instruments: Autostainer Link 48, Model AS480
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Dako Autostainer instruments: Autostainer Link 48, Model AS480 by Dako Denmark A S, citing the Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2074-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-05 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Dako Denmark A S |
| Distribution | US |
Product
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Reason
The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.
Identifiers
| code_info | All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2074-2020%22
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