Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-0519-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 2, 2013

Date Posted: December 25, 2013

Recall Number: Z-0519-2014

Event ID: 66521

Reason for Recall:

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). I

Status: Terminated

Product Quantity: 16,154 units

Code Information:

Part Number 81901, Lot Numbers: 13181168-13341170.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.

Voluntary or Mandated:

Voluntary: Firm initiated