Recall of Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8

Recall

66694

Class 2

Z-0823-2014

2013-10-30

2014-01-24

Terminated

United States

2014-12-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122995

Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (disabled test in centralink system or aptio system may become enabled in centralink system.).

The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated October 23, 2013 to its customers. The firm also sent a follow-up letter dated October 30, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed Until a service visit is scheduled, do the following: Instruct the laboratory staff to recognize this sequence of events and Ensure that whenever the operator disables a method on an Aptio system or a CentraLinksystem and replenishes reagent for that method, the operator then confirms that the method remains disabled in the CentraLink system or disables it again. The operator must allow up to five minutes to verify that the test remains disabled. In addition, the customers were instructed tocomplete and return the FIELD CORRECTION EFFECTIVENESS CHECK response form via fax to Siemens Healthcare Diagnostics Customer Care Center at 800-441-9250, and to retain this letter with your laboratory records, and forward this letter to those who may have received this product. After a service visit is performed and an interim solution is implemented, the laboratory staff will be trained on this update to understand the minor but necessary changes in the workflow. If you have any questions, please contact your Siemens Customer Care Center at 800-441-9250 or your local Siemens representative.