Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-0612-2013)

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 System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. 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. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.

Product Classification:

Class II

Date Initiated: November 1, 2012

Date Posted: January 2, 2013

Recall Number: Z-0612-2013

Event ID: 63632

Reason for Recall:

It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.

Status: Terminated

Product Quantity: 6,858 units

Code Information:

Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated