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.
What this means for you
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 reques
- Manufacturer
- Dako North America Inc.
- Category
- Medical Device — Software
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
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