Z-1548-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2015
- Initiation Date
- April 1, 2015
- Termination Date
- August 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 (7 in U.S. and 26 Internationally)
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.
Distribution Pattern
Worldwide Distribution - U.S Nationwide in the states of IN and PA and the countries of: Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, UK, and Korea.
Code Information
N/A Serial Number: 1311004352, 1308004862, 1307000537, 1405002266, 1410008844, 1307006995, 1311001075, 1402002186, 1401010308, 1402005995, 1306001697, 1311007317, 1410004066, 1404006200, 1410004067, 1405002263, 1404007225, 1410002144, 1311007321, 1404004226, 1401005960, 1305006010, 1401000919, 1405000371, 1401005963, 1403005465, 1304008205, 1401003711, 1401001048, 1310010425, 1401003715, 1311004354, 1311004355