Dako North America Inc. recalls Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide sta…

Recall date

April 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1548-2015

FDA classification

Class II

Brand / firm

Dako North America Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.