ClearanceBrief
Recall Z-2716-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Siemens Healthcare Diagnostics

ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical a

DateSep 29, 2014 (initiated Aug 19, 2014)
StatusTerminated
ReasonThe 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
Root causeSoftware design
ActionSiemens 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. P
QuantityDomestic: 2771 units; Foreign: 7744 units
DistributionWorldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Brita
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Bayer Healthcare, LLC, Jul 2, 2004