PlainRecalls
FDA Devices Moderate Class II 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.

Reported: January 21, 2015 Initiated: December 16, 2014 #Z-0987-2015

Product 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.

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.

Details

Units Affected
7
Distribution
Distributed in the state of WA.
Location
Newark, DE

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 7.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0987-2015.

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