Recall Z-0860-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0860-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-09

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-10-09, terminated 2017-03-16. It names one FDA 510(k) clearance: K041133. Product: ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.. Reason: A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Terminated: 2017-03-16
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 XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.

Reason for recall

A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

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