Recall Z-0985-2014— Beckman Coulter Inc.

Name: FDA recall Z-0985-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2013-11-26, terminated 2014-07-27. It names one FDA 510(k) clearance: K023764. Product: UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.. Reason: The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Terminated: 2014-07-27
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K023764 — UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100Beckman Coulter, Inc.·cleared 2003-01-28

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

UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Reason for recall

The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

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