CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instru

FDA device recall Z-1957-2015 · posted 2015-07-02 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.

Action taken

Siemens sent an Urgent Medical Device Correction letter dated May 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer When using any of the CentraLink sample queries, do not select Instrument or Instrument Group criteria for Dimension Vista 500 or Dimension Vista 1500. This would also include any preconfigured queries, commands or tool bar buttons that may use these criteria. Your local Siemens service provider will be contacting you to verify and/or update the configuration of your CentraLink system. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions please call (800) 441-9250.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JQP

Quantity affected

1941

Distribution

Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Ki

Date initiated

2015-05-19

Date posted

2015-07-02

Date terminated

2018-04-27

Location

Newark, DE