Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-1035-2013)

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:

UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Product Classification:

Class II

Date Initiated: February 12, 2013

Date Posted: April 10, 2013

Recall Number: Z-1035-2013

Event ID: 64332

Reason for Recall:

Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.

Status: Terminated

Product Quantity: 956 units

Code Information:

Part # A25640, A25638, A25656, A25637; All Serial Numbers

Distribution Pattern:

Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated