Beckman Coulter Inc.: Medical Device Recall in 2014 - (Recall #: Z-0984-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Access 2 Immunoassay System Analyzer. 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: November 26, 2013

Date Posted: February 26, 2014

Recall Number: Z-0984-2014

Event ID: 66958

Reason for Recall:

The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

Status: Terminated

Product Quantity: 3 units

Code Information:

Part Number 81600N. Serial Numbers 508957, 508963, 508964.

Distribution Pattern:

Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.

Voluntary or Mandated:

Voluntary: Firm initiated