Z-0313-2025Class II

The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative...

Name: Z-0313-2025 The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative...
Creator: Beckman Coulter, Inc.
Published: 2024-09-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-09-30 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma... on 2024-09-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0313-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-30
Posted: 2024-11-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CGR Radioimmunoassay, Cortisol
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 149 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 15099590231118, all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0313-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0313-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-06

Product code CGR

K223038Class IIAccess CortisolBeckman Coulter, Inc. / cleared 2023-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)