Recall Z-1548-2015— Dako North America Inc.
Class II · Terminated
Class II FDA medical device recall by Dako North America Inc., initiated 2015-04-01, terminated 2015-08-05. FDA's recall record names no specific 510(k) clearance for this event. 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 requests from LIS or manual entries to connected Dako systems.. Reason: 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..
- Recalling firm
- Dako North America Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-01
- Terminated
- 2015-08-05
- Firm location
- Carpinteria, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.