Z-2074-2020Class II

Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model...

Name: Z-2074-2020 Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model...
Creator: Dako Denmark A/S
Published: 2019-11-05
License: https://open.fda.gov/license/

Agilent Technologies Denmark ApS / initiated 2019-11-05 / Terminated / root cause: manufacturing process

FDA source

Dako Denmark A/S began a recall of Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus... on 2019-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2074-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-05
Posted: 2020-05-21
Terminated: 2022-05-17
Recalling firm: Agilent Technologies Denmark ApS
Product: Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Product code: KPA Slide Stainer, Automated
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued letters dated 10/30/2019 via email or standard mail, or phone call beginning 11/5/2019 notifying the customer of the issue, providing the risk to health, and actions that needed to be taken. On 09/03/2020, Agilent Dako sent Urgent Field Safety Notices to customers who were asked to take the following actions: 1) Carefully read and communicate to those within your organization of the updates stated in this notification letter and attached Autostainer Link Basic User Guide (rev. 06). Your local sales team will confirm with you that you have read and acknowledged this notification. 2) Your Agilent representative should be contacted immediately for assistance in the event of leakage. 3) Please discard previous versions of the Autostainer Link Basic User Guide that you are currently using.
Quantity in commerce: 796 devices
Distribution: 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, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Morocco, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Poland, Qatar, Romania, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, and Vietnam.
Product codes and lots: All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2074-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2074-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)