Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0313-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

Product Classification:

Class II

Date Initiated: September 30, 2024

Date Posted: November 13, 2024

Recall Number: Z-0313-2025

Event ID: 95473

Reason for Recall:

The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.

Status: Ongoing

Product Quantity: 149 units

Code Information:

UDI/DI 15099590231118, all lots

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated