device · product 1 of 1
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
- Recall number
- Z-2074-2020
- Initiated
- November 05, 2019
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Dako Denmark A/S
- Quantity
- 796 devices
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
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.
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.
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.