Company: Beckman Coulter Inc..
Date of Enforcement Report 11/12/2014
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 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.
Recall Number Z-0175-2015
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a “MFC Exception” error during normal operation of the Access 2 Immunoassay Systems.
Beckman Coulter Inc., Brea, CA on 10/6/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,519 units total (403 units total)
Nationwide and Internationally