Use cautionMedical device recall · FDA · Published September 30, 2024
Beckman Coulter Access Cortisol Assay Recall: Incorrect Calibration May Cause Measurement
Beckman Coulter recalls Access Cortisol assay kits due to potential calibration failures from incorrect calibration curve parameters, which may delay results and cause injuries. Affected units include all lots with UDI/DI 15099590231118.
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.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter Access Cortisol Assay Recall: Incorrect Calibration May Cause Measurement.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53848-beckman-coulter-access-cortisol-assay-recall-incorrect-calibration-may-cause. Based on FDA recall #Z-0313-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0313-2025%22&limit=1).
The FDA announced on September 30, 2024, that Beckman Coulter, Inc. is recalling The Access Cortisol assay due to a calibration error that may cause measurement delays and potential injuries. The firm initiated this voluntary Class II recall affecting all lots of the device distributed worldwide.
How to tell if you have it
Brand: Beckman Coulter
Product: The Access Cortisol assay
Description: Paramagnetic particle, chemiluminescent immunoassay for quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
UDI/DI: 15099590231118
Lots: All lots
Quantity: 149 units
The hazard
The Access Cortisol assay protocol file applies an incorrect calibration curve acceptance parameter at the S1 calibrator level, which can lead to a high rate of calibration failures varying by reagent lot number. This failure causes delays in reporting measurement results and potential injuries.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Recent brand recalls include the DxC 500i Modules with Software 1.5 recall on July 15, 2026, and the MicroScan LabPro V5.03 Panel Update 11 DVD Kit recall on June 26, 2026. Other recent recalls of similar products include the AU5800 Chemistry Analyzer Recall (January 30, 2026), the Emit 2000 Quinidine Assay Recall (July 13, 2026), and the DxC 700 AU Recall (January 30, 2026).
How to tell if you have this one
Check for the UDI/DI number 15099590231118 on the kit packaging. All lots of this specific Access Cortisol assay are affected.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Status
Verify if your kit has the UDI/DI number 15099590231118 by checking the packaging.
How this recall unfolded
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0313-2025 (September 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0313-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.