Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostain

FDA device recall Z-2074-2020 · posted 2020-05-21 · Terminated

Recall details

Recalling firm

Dako Denmark A/S

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KPA

Quantity affected

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, De

Date initiated

2019-11-05

Date posted

2020-05-21

Date terminated

2022-05-17

Location

Glostrup, Denmark