—#210348

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.

FDA product code: CGR — Radioimmunoassay, Cortisol
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K223038
Affected lot / code info: UDI/DI 15099590231118, all lots

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-09-30
Posted by FDA: 2024-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210348. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.