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Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, ...

FDA Device Recall #Z-1548-2015 — Class II — April 1, 2015

Recall Summary

Recall Number Z-1548-2015
Classification Class II — Moderate risk
Date Initiated April 1, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dako North America Inc.
Location Carpinteria, CA
Product Type Devices
Quantity 33 (7 in U.S. and 26 Internationally)

Product Description

Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.

Reason for Recall

If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request was rejected.

Distribution Pattern

Worldwide Distribution - U.S Nationwide in the states of IN and PA and the countries of: Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, UK, and Korea.

Lot / Code Information

N/A Serial Number: 1311004352, 1308004862, 1307000537, 1405002266, 1410008844, 1307006995, 1311001075, 1402002186, 1401010308, 1402005995, 1306001697, 1311007317, 1410004066, 1404006200, 1410004067, 1405002263, 1404007225, 1410002144, 1311007321, 1404004226, 1401005960, 1305006010, 1401000919, 1405000371, 1401005963, 1403005465, 1304008205, 1401003711, 1401001048, 1310010425, 1401003715, 1311004354, 1311004355

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-1261-2015 Class II Autostainer Link 48 (AS480), Autostainer Plus L... Feb 12, 2015
Z-2708-2014 Class II Dako Autostainer Link 48 with software version ... Aug 29, 2014

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

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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