Recall Z-0984-2014— Beckman Coulter Inc.

Name: FDA recall Z-0984-2014
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: K922823. Product: Access 2 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

K922823 — ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTSBio-Rad Laboratories, Inc.·cleared 1992-08-05

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

Access 2 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.