Reported Mar 18, 2015 · Terminated
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus…
Dako North America Inc.
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 North America Inc. · 6392 Via Real · Carpinteria, CA · 93013-2921
Is this the product you have?
- Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
- Lot codes and dates
992640 Rev. 02992085 Rev.no H992625 Rev.no F992326 Rev
- no C Affected dates12/2013-08/2014 Each device is labeled with a unique serial number
- Catalog/Model Number- AS480 - S3800 - S3400 - AS100
- Amount recalled
- 409
Where it was sold
Why it was recalled
A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.
This product could cause temporary or reversible health problems — stop using it.
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