Z-1548-2015Class II

Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated...

Name: Z-1548-2015 Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated...
Creator: Dako North America Inc.
Published: 2015-04-01
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2015-04-01 / Terminated / root cause: labeling and UDI

FDA source

Dako North America Inc. began a recall of 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... on 2015-04-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1548-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-01
Posted: 2015-04-29
Terminated: 2015-08-05
Recalling firm: Agilent Technologies, Inc.
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.
Product code: KPA Slide Stainer, Automated
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Dako sent a Voluntary Product Recall Notification letter starting the week of April 1, 2015 along with a acknowledgement attachment. The letter identified the affected product, problem and actions to be taken. The firm requests that customers inform those in their organization of the notification including organizations where the potentially affected instruments have been transferred. The firm requests that customers complete, sign, and return the acknowledgement form within one week after receiving the notification. For questions contact your Dako sales representative. On 04/29/15 the firm sent out an updated customer notification letter in order to provide additional clarification and instructions to customers in regards to the recall situation.
Quantity in commerce: 33 (7 in U.S. and 26 Internationally)
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1548-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1548-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)