Dako North America recalls

Dako North America has 8 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 18 Jul 2018.

Total recalls8since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Jul 2018

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why dako north america is recalled

Product types

Test Kits & Diagnostics788%
Other Medical Devices113%

By year

2018113%
2016113%
2015338%
2014225%
2012113%

All dako north america recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
18 Jul 2018Device	CLASS II	PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to recalled	Dako North America	Other	29 states
6 Jul 2016Device	CLASS II	Dako HER2 CISH pharmDx Kit, product recalled by Dako North America	Dako North America	Other	Nationwide
11 Nov 2015Device	CLASS II	EnVision Flex/Hrp visualization reagent found recalled	Dako North America	Packaging Defects	Nationwide
6 May 2015Device	CLASS II	Test Request Distributor (TRD 3 and TRD 4) recalled	Dako North America	Device Malfunction	Nationwide
18 Mar 2015Device	CLASS II	Autostainer Plus Link Instrument (AS100) recalled by Dako North America	Dako North America	Packaging Defects	Nationwide
1 Oct 2014Device	CLASS II	Dako Autostainer Link recalled by Dako North America	Dako North America	Device Malfunction	Nationwide
5 Mar 2014Device	CLASS II	HER2 CISH pharmDx Kit recalled by Dako North America	Dako North America	Other	Nationwide
21 Nov 2012Device	CLASS II	PT Link Waterbath recalled by Dako North America	Dako North America	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.