Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access 2 Immunoassay Systems Recalled by Beckman Coulter Inc. Due to Beckman Coulter is recalling the Small Form Factor...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.
Affected Products
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.
Quantity: 1,519 units total (403 units total)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report