Agency classClass IIOur severity:High FDA (Devices)·Z-1548-2015·Announced 2015-05-06

Dako Omnis Software Module Recalled for Test Request Errors

Dako North America is recalling the Test Request Distributor software module for the Dako Omnis System because it may execute the wrong test after a user updates a request.

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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect test execution) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Dako North America Inc. is recalling the 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 recall involves 33 units, with 7 located in the United States (specifically in Indiana and Pennsylvania) and 26 located internationally in Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, the UK, and Korea.

The recall is due to a software defect where the system may reject an updated test request without warning the user. If a user requests slides from the Laboratory Information System (LIS) or Test Plan Information Display (TPID) and then updates the request by changing the test, the TRD software will reject the update. However, the LIS and printed slide label will display the updated test, while the Omnis system will execute the initial test, not reflecting the change. The system does not warn the user that the test request was rejected.

This discrepancy could lead to the execution of the wrong test, potentially affecting diagnostic results. Users of the affected software modules should contact Dako North America Inc. for further instructions on how to resolve the issue.

The recalled product

Product: 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…
Manufacturer: Dako North America Inc.
Category: Medical Device — Software
Hazard: software-defect
incorrect-test

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 (20)

N/A Serial Number: 1311004352
1308004862
1307000537
1405002266
1410008844
1307006995
1311001075
1402002186
1401010308
1402005995
1306001697
1311007317
1410004066
1404006200
1410004067
1405002263
1404007225
1410002144
1311007321
1404004226

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Dako North America Inc.

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