# FDA recall Z-0313-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-09-30.

## Product

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.

## 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.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0313-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-30
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0313-2025

## Citation

> AI Analytics. FDA recall Z-0313-2025. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0313-2025. Source: US FDA. Licensed CC0.

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