FDA Device recall Z-0313-2025
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in…
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in… by Beckman Coulter, citing 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 fa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0313-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-30 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
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
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.
Identifiers
| code_info | UDI/DI 15099590231118, all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0313-2025%22
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