Z-0313-2025 Class II Ongoing
FDA device recall Z-0313-2025 was initiated by Beckman Coulter, Inc. on September 30, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 149 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- September 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 units
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.
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 Pattern
Worldwide distribution.
Code Information
UDI/DI 15099590231118, all lots