Dako Autostainer Instruments Recalled for Potential False Negative Staining Results
Dako is recalling 796 Autostainer instruments because a missing syringe tray may cause excess buffer application, potentially leading to false negative staining 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, but the hazard (false negative results) poses a significant risk to patient care.
Plain-English summary
Dako Denmark A/S is recalling 796 Dako Autostainer instruments, including the Autostainer Link 48 (Model AS480), Autostainer Plus Link Instrument (Model AS100), Autostainer (Model S3400), and Autostainer Plus (Model S3800). The recall affects devices manufactured between July 22, 1997, and June 28, 2018, that do not have an installed syringe tray. The UDI for the affected devices is 05700572035497.
The recall was initiated because the absence of a syringe tray may result in a small volume of excess buffer being applied to several slides. This condition, combined with potential leakage of buffer and/or reagents, may impact staining and increase the potential risk of false negative results. The updated Basic User Guide is intended to reduce this risk.
Distribution was nationwide, including government and military channels, as well as foreign distribution to numerous countries including Canada, Australia, and various nations in Europe, Asia, and the Americas. Users should check their devices for the presence of a syringe tray and consult the updated Basic User Guide to mitigate the risk of false negative results.
The recalled product
- Product
- Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
- Manufacturer
- Dako Denmark A/S
- Affected units
- 796
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 (1)
- UDI 05700572035497.
Distribution
Distributed nationwide across the United States.
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