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) a

Hazard

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.

Details from the source

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. Distribution: Worldwide distribution. Quantity: 149 units Lot/code info: UDI/DI 15099590231118, all lots

UPC codes

15099590231118

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.