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Terminated

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.

FDA Recall Z-0987-2015 · Posted 2015-01-15

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-12-16
Date Terminated2016-10-27
Product Quantity7

Reason for Recall

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed in the state of WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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