Reported May 6, 2015 · Terminated
Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide…
Dako North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dako North America Inc. · 6392 Via Real · Carpinteria, CA · 93013-2921
Is this the product you have?
- 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.
- Lot codes and dates
- N/A Serial Number
131100435213080048621307000537140500226614100088441307006995131100107514020021861401010308140200599513060016971311007317141000406614040062001410004067140500226314040072251410002144131100732114040042261401005960130500601014010009191405000371140100596314030054651304008205140100371114010010481310010425140100371513110043541311004355
- N/A Serial Number
- Amount recalled
- 33 (7 in U.S. and 26 Internationally)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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