ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink 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.
Recall
- Recall Number
- Z-0987-2015
- Event Number
- 70078
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- JQP
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 16, 2014
- Posted
- January 15, 2015
- Terminated
- October 27, 2016
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466
Description
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink 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.
Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.
A Siemens service provider visited each site to verify and/or update customer configuration on the ADVIA Chemistry XPT and CentraLink Systems to ensure proper reporting of results. An Urgent Medical Device Correction letter was issued on December 16, 2014 to all affected customers. Customers were also provided a Customer Bulletin providing instructions on how configuration setting should remain.
Distributed in the state of WA.
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