Recall Z-1615-2016— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1615-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-30

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-03-30, terminated 2017-03-29. It names one FDA 510(k) clearance: K041133. Product: ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.. Reason: The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-03-30
Terminated: 2017-03-29
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 CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.

Reason for recall

The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

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