Aug

2012

Cl ll UniCel DxI Access Immunoassay Systems

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll UniCel DxI Access Immunoassay Systems

Amy Sellers

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