medical Class II Updated 2024-11-13

Beckman Coulter, Inc. recalls The Access Cortisol assay is a paramagnetic particle, chemil

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: UDI/DI 15099590231118, all lots
View official government recall

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