medical Class II Updated 2020-05-27

Dako Denmark A/S recalls Dako Autostainer instruments: Autostainer Link 48, Model A

Recalled Product

Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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.
View official government recall

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