Home / Recalls / Dako Denmark A/S / Z-2074-2020

Z-2074-2020 Class II Terminated

Recalled by Dako Denmark A/S — Glostrup, N/A

FDA device recall Z-2074-2020 was initiated by Dako Denmark A/S on November 5, 2019 and is designated Class II. 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 Bas… The recall status is terminated (terminated May 17, 2022). Affected quantity: 796 devices.

Recall Details

Product Type: Devices
Report Date: May 27, 2020
Initiation Date: November 5, 2019
Termination Date: May 17, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 796 devices

Product Description

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

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.

Distribution Pattern

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.

Code Information

All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.