ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a labora

FDA device recall Z-2715-2014 · posted 2014-09-29 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full

Action taken

Siemens sent an Urgent Medical Device Correction Letter dated August 19, 2014, via Fed Ex to US customers and via email to regional countries for implementation outside the US (OUS). The letter identified the product the problem and the action needed to be taken by the customer. The letters inform the customers of the issue and specific actions to be taken if the instrument is interfaced to an LIS system that transmits patient demographics with each order. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions. Please complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed form to the Customer Care Center at (302) 631-7597. If you have any questions, contact your local Siemens technical support representative

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

Domestic: 2771 units; Foreign: 7744 units

Distribution

Worldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croat

Date initiated

2014-08-19

Date posted

2014-09-29

Date terminated

2018-05-22

Location

Tarrytown, NY

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