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.
Beckman Coulter is recalling its Access Cortisol assay kits because a faulty calibration process could cause measurement delays and potential injuries. This affects all units with the specific UDI/DI number listed in the recall.
The assay protocol file uses an incorrect calibration curve acceptance parameter at the S1 calibrator level. This can cause calibration failures that vary by reagent lot, potentially delaying test results and leading to injuries.
Healthcare professionals using the Access Cortisol assay kits for cortisol testing are most at risk. The recall applies to all units with the UDI/DI number 15099590231118.
Check for the UDI/DI number 15099590231118 on the kit packaging. All lots of this specific Access Cortisol assay are affected.
Verify if your kit has the UDI/DI number 15099590231118 by checking the packaging.
The Access Cortisol assay protocol file applies an incorrect calibration curve acceptance parameter at the S1 calibrator level, which can cause calibration failures and potential injuries.
Check the UDI/DI number on the packaging. If it matches 15099590231118, contact Beckman Coulter for further instructions.
Calibration failures could delay test results and potentially cause injuries, but the recall does not specify a direct risk of serious injury in normal use.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0313-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0313-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
