Recall Z-2715-2014— Siemens Healthcare Diagnostics

Name: FDA recall Z-2715-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-19

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2014-08-19, terminated 2018-05-22. It names one FDA 510(k) clearance: K041133. Product: 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.. Reason: 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.

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-08-19
Terminated: 2018-05-22
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K041133 — MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERBayer Healthcare, LLC·cleared 2004-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.