Recall Z-1957-2015 ยท JQP Calculator/Data Processing Module, For Clinical Use
Siemens Healthcare Diagnostics, Inc.
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
| Date | Jul 2, 2015 (initiated May 19, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 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 Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.