Company: Beckman Coulter Inc.
Date of Enforcement Report 8/29/12
Class ll:
PRODUCT
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI 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-2257-2012
REASON
The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA Greenville, SC on 10/13/2011. Voluntary: Firm Initiated recall has been terminated.
VOLUME OF PRODUCT IN COMMERCE
2442 units total (784 units in US)
DISTRIBUTION
Nationwide and Internationally
