Company: Dako North America Inc.
Date of Enforcement Report: 5/6/2015
Class lI:
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.
Recall Number Z-1548-2015
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/MANUFACTURER
Dako North America Inc.,Carpinteria, CA on 4/1/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
37
DISTRIBUTION
Nationwide and Internationally
___________________________________
