Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-0291-2014)

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 2 Immunoassay System, Part Number: 81600N 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: September 12, 2013

Date Posted: November 20, 2013

Recall Number: Z-0291-2014

Event ID: 66397

Reason for Recall:

Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

Status: Terminated

Product Quantity: 8 units total (1 unit in the US)

Code Information:

Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810

Distribution Pattern:

Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.

Voluntary or Mandated:

Voluntary: Firm initiated