Dako Denmark A/S recalls Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostai…

Recall date

November 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2074-2020

FDA classification

Class II

Brand / firm

Dako Denmark A/S

Sold / distributed

Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Australia, Bangaladesh, Belarus, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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