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Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and A...

FDA Device Recall #Z-1261-2015 — Class II — February 12, 2015

Recall Summary

Recall Number Z-1261-2015
Classification Class II — Moderate risk
Date Initiated February 12, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dako North America Inc.
Location Carpinteria, CA
Product Type Devices
Quantity 409

Product Description

Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.

Lot / Code Information

992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C Affected dates: 12/2013-08/2014 Each device is labeled with a unique serial number. Catalog/Model Number: - AS480 - S3800 - S3400 - AS100

Other Recalls from Dako North America Inc.

Recall # Classification Product Date
Z-2425-2018 Class II PD-L1 IHC 22C3 pharmDx is a companion diagnosti... Feb 2, 2018
Z-2099-2016 Class II Dako HER2 CISH pharmDx Kit, product code: SK 10... Jun 10, 2016
Z-0220-2016 Class II EnVision FLEX/HRP visualization reagent found i... Sep 4, 2015
Z-1548-2015 Class II Test Request Distributor (TRD 1.3 and TRD 1.4),... Apr 1, 2015
Z-2708-2014 Class II Dako Autostainer Link 48 with software version ... Aug 29, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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