Device 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.
Z-0313-2025
Product summary
- Event
- Event 95473
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 149 units
- Official record key
device-enforcement:Z-0313-2025
Official wording
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.
Code information: UDI/DI 15099590231118, all lots
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.