Home / Recalls / Dako North America Inc. / Z-1548-2015

Z-1548-2015 Class II Terminated

Recalled by Dako North America Inc. — Carpinteria, CA

FDA device recall Z-1548-2015 was initiated by Dako North America Inc. on April 1, 2015 and is designated Class II. 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 recall status is terminated (terminated August 5, 2015). Affected quantity: 33 (7 in U.S. and 26 Internationally).

Recall Details

Product Type
Devices
Report Date
May 6, 2015
Initiation Date
April 1, 2015
Termination Date
August 5, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33 (7 in U.S. and 26 Internationally)

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.

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.

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.

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

Other recalls by Dako North America Inc.

  • Z-2425-2018 Class II — PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels (February 2, 2018)
  • Z-2099-2016 Class II — Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro (June 10, 2016)
  • Z-0220-2016 Class II — EnVision FLEX/HRP visualization reagent found in the following kits: EnVision F (September 4, 2015)
  • Z-1261-2015 Class II — Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostain (February 12, 2015)
  • Z-2708-2014 Class II — Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 (August 29, 2014)
  • Z-1093-2014 Class II — Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 (January 21, 2014)
  • Z-0287-2013 Class II — PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automat (May 1, 2008)

FDA data resources