ADVIA Centaur 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 and laboratory findings have been evaluated.

Recall Insight

This FDA Devices action (record #Z-2715-2014) was formally reported on October 8, 2014, with the manufacturer initiating the action on August 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as Domestic: 2771 units; Foreign: 7744 units.

The documented reason for this recall is: 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 d… Distribution data in the federal record shows the product reached: Worldwide 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.