Dako Automated Slide Stainers Recalled for Potential Diagnostic Errors
Dako North America Inc. is recalling four models of automated slide stainers because a defect may cause buffer leakage, leading to false negative diagnostic results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (false negative diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Dako North America Inc. is recalling 409 units of four models of automated slide stainers: Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). These devices are used for in vitro diagnostic purposes. The recall affects units manufactured between December 2013 and August 2014.
The recall is due to a defect in the syringe assembly stopcock component. In some circumstances, this defect may cause excess buffer to leak onto specific slide locations: location 34 on the AS480, or locations 35 and 36 on the AS100, S3400, and S3800. This leakage can result in false negative test results, which may affect patient diagnosis.
The affected devices were distributed worldwide, including the United States and several countries in Europe, Asia, and Oceania. Each device is labeled with a unique serial number. Users should check their device serial numbers against the recall information and contact Dako North America Inc. for further instructions.
The recalled product
- Product
- Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
- Manufacturer
- Dako North America Inc.
- Hazard
- Affected units
- 409
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 992640 Rev. 02
- 992085 Rev.no H
- 992625 Rev.no F
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Dako North America Inc.
See all →- ModerateDako PD-L1 IHC 22C3 pharmDx Recall for Storage Time Correction
FDA (Devices) · 2018-07-18
- ModerateDako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration
FDA (Devices) · 2016-07-06
- ModerateDako EnVision FLEX Visualization Reagent Recalled for Staining Defect
FDA (Devices) · 2015-11-11
- HighDako Omnis Software Module Recalled for Test Request Errors
FDA (Devices) · 2015-05-06
- ModerateDako Autostainer Link 48 Software Recall for Reagent Handling Issues
FDA (Devices) · 2014-10-01
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- HighDako Autostainer Instruments Recalled for Potential False Negative Staining Results
FDA (Devices) · 2020-05-27
- ModerateDako Autostainer Link 48 Software Recall for Reagent Handling Issues
FDA (Devices) · 2014-10-01
- HighDako CoverStainer Microscope Slide Stainer Recalled for Plexiglass Door Breakage
FDA (Devices) · 2024-06-05
- ModerateDako CoverStainer Slide Rack Recalled for Performance Defects
FDA (Devices) · 2012-12-26
- SevereLeica HistoCore SPECTRA ST Slide Stainer Recalled for Electrical Safety Hazard
FDA (Devices) · 2018-10-10
- HighDako Omnis Software Module Recalled for Test Request Errors
FDA (Devices) · 2015-05-06