Recall Z-2074-2020 ยท KPA Slide Stainer, Automated
Dako Denmark A/S
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
| Date | May 21, 2020 (initiated Nov 5, 2019) |
| Status | Terminated |
| Reason | 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 | 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 notificati |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.