CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instru...
FDA Device Recall #Z-0563-2013 — Class II — November 26, 2012
Recall Summary
| Recall Number | Z-0563-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 26, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dako Denmark A/S |
| Location | Glostrup |
| Product Type | Devices |
| Quantity | 25 Units US (50-100 racks per unit) 106 total |
Product Description
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance.
Reason for Recall
The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the following countries: Australia France Rep. of Korea Belgium Germany Russia Brazil Israel Saudi Arabia Canada Italy Spain Chile Japan Sweden China Mexico Taiwan Denmark Netherlands Turkey Ecuador Norway UK Finland Poland
Lot / Code Information
The racks affected by this recall were distributed with the following CoverStainer instrument serial numbers in the U.S.: CS 100-10031 CS 100-10033 CS 100-10035 CS 100-10054 CS 100-10080 CS 100-10081 CS 100-10082 CS 100-10083 CS 100-10093 CS 100-10094 CS 100-10106 CS 100-10107 CS 100-10110 CS 100-10113 CS 100-10117 CS 100-10123 CS 100-10124 CS 100-10125 CS 100-10133 CS 100-10135 CS 100-10148 CS 100-10149 CS 100-10150 CS 100-10152 CS 100-10159
Other Recalls from Dako Denmark A/S
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2074-2020 | Class II | Dako Autostainer instruments: Autostainer Lin... | Nov 5, 2019 |
| Z-2330-2016 | Class II | EnVision FLEX+, Mouse, High pH (Link), Product ... | Jul 6, 2016 |
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.