Reported May 27, 2020 · Terminated
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100;…
Dako Denmark A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dako Denmark A/S · Produktionsvej 42 · Glostrup, N/A · N/A
Is this the product you have?
- Dako Autostainer instruments
Autostainer Link 48Model AS480Autostainer Plus Link InstrumentModel AS100AutostainerModel S3400and Autostainer PlusModel S3800
- Lot codes and dates
- All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.
- Amount recalled
- 796 devices
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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