Recall Z-0313-2025 ยท CGR Radioimmunoassay, Cortisol
Beckman Coulter, Inc.
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.
| Date | Nov 6, 2024 (initiated Sep 30, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 149 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223038 | Access Cortisol Beckman Coulter, Inc., Feb 8, 2023 |