Nov

2014

Cl II Access 2 Immunoassay Systems

Company: Beckman Coulter Inc..
Date of Enforcement Report 11/12/2014
Class lI:

PRODUCT

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

REASON
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.

RECALLING FIRM/MANUFACTURER
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)

DISTRIBUTION
Nationwide and Internationally

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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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Cl II Access 2 Immunoassay Systems

Amy Sellers

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