FDAFDA · Food and drugs·Recall number Z-0313-2025
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.
Published November 13, 2024 · Recall initiated: September 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter, Inc.
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI 15099590231118, all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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