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U.S. Department of Health and Human Services

Class 2 Device Recall Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module

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  Class 2 Device Recall Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module see related information
Date Initiated by Firm April 01, 2015
Date Posted April 29, 2015
Recall Status1 Terminated 3 on August 05, 2015
Recall Number Z-1548-2015
Recall Event ID 70898
Product Classification Slide stainer, automated - Product Code KPA
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.
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                                   
Recalling Firm/
Manufacturer		 Dako North America Inc.
6392 Via Real
Carpinteria CA 93013-2921
For Additional Information Contact
805-566-6655
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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