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Recall Observatory FDA recall evidence

Device 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.

Z-1548-2015

April 01, 2015

Class II

Product summary

Firm
Dako North America Inc.
Event
Event 70898
Status
Terminated
Classification
Class II
Quantity
33 (7 in U.S. and 26 Internationally)
Official record key
device-enforcement:Z-1548-2015

Official wording

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.

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

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software will reject the update. The LIS and printed slide label will