25

Dec

2013

Cl II Access Immunoassay Systems Reaction Vessels

0

Company: Beckman Coulter Inc.
Date of Enforcement Report:12/25/2013
Class lI:

PRODUCT

Access Immunoassay Systems Reaction Vessels. 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. Recall Number Z-0519-2014

REASON
Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System ”Wash Carousel Motion Errors” with specific lots of Access System Reaction Vessels (RVs). If your system is experiencing these errors, the errors will be documented in the event log and the system will be in the Not Ready mode..

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA on 10/2//2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16,154 units

DISTRIBUTION
Nationwide and Internationallyp>

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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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