ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink

FDA device recall Z-0987-2015 · posted 2015-01-15 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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

Status

Terminated

Product code

JQP

Quantity affected

7

Distribution

Distributed in the state of WA.

Date initiated

2014-12-16

Date posted

2015-01-15

Date terminated

2016-10-27

Location

Newark, DE