Devices

Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module

Model / Serial
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
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
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.
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.
Manufacturer
Dako North America Inc.
1 Event
- Recall of Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module

Manufacturer

Dako North America Inc.

Manufacturer Address
Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
Manufacturer Parent Company (2017)
Agilent Technologies, Inc.
Source
USFDA

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