Dako Autostainer instruments: Autostainer Link 48, Model… recallZ-2074-2020 · Dako Denmark A/S · initiated Nov 5, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dako Denmark A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2074-2020
- Status
- Terminated
- Initiated by the company
- Nov 5, 2019
- Posted by the FDA
- May 21, 2020
- Recalling firm
- Dako Denmark A/S
- Quantity
- 796 devices
- Product code
- KPA
- 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 description
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Code information (models, lots, serial numbers)
All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Autostainer Link 48 AS480Agilent Technologies Singapore Pte Ltd · Slide stainer, automated1 recall723 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page