Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1901-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Access Testosterone assay, Catalog Number 33560

Product Classification:

Class II

Date Initiated: May 5, 2025

Date Posted: June 11, 2025

Recall Number: Z-1901-2025

Event ID: 96824

Reason for Recall:

Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.

Status: Ongoing

Product Quantity: 70 units

Code Information:

UDI-DI: 15099590231347; Serial Number: 538081

Distribution Pattern:

US State: FL. UAE, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated