The Access Cortisol assay is a paramagnetic particle… recallZ-0313-2025 · Beckman Coulter, Inc. · initiated Sep 30, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
Beckman Coulter issue and URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2024 via letter (USPS) and email. The notice explained the issue, the impact to the patient, and requested the use of alternative lot of Access Cortisol reagent. In the event the laboratory cannot generate a passing calibration curve use alternative methodology including alternative Beckman Coulter Access Immunoassay Systems. Beckman Coulter will release an updated Access Cortisol APF on the DxI 9000 Access Immunoassay Analyzer that includes the correct calibration curve acceptance parameter at the S1 calibrator level. A Beckman Coulter representative will contact you when the updated APF is available. The notice is to be shared with laboratory staff and forwarded to all parties to whom the the affected product was distributed.
Recall details
- Recall number
- Z-0313-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 30, 2024
- Posted by the FDA
- Nov 6, 2024
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 149 units
- Product code
- CGR
- FDA submissions
- K223038
- Distribution
- Worldwide distribution.
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.
Code information (models, lots, serial numbers)
UDI/DI 15099590231118, all lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access Cortisol 33600Beckman Coulter, Inc. · Radioimmunoassay, Cortisol1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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