Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Test Request Distributor (TRD 1.3 and TRD 1.4) Recalled by Dako North America Inc. Due to If a user requests slides from the LIS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dako North America Inc. directly.
Affected Products
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.
Quantity: 33 (7 in U.S. and 26 Internationally)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dako North America Inc.
Dako North America Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report