Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Product Codes/Lot Numbers:
All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2074-2020
Related Recalls
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Dako Denmark A/S
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.