Recall Z-2074-2020— Dako Denmark A/S
Class II · Terminated
Class II FDA medical device recall by Dako Denmark A/S, initiated 2019-11-05, terminated 2022-05-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.. 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..
- Recalling firm
- Dako Denmark A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-05
- Terminated
- 2022-05-17
- Firm location
- Glostrup, N/A, Denmark
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.