Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA

Recalled May 10, 2023 · FDA recall Z-1505-2023 · Siemens Healthcare Diagnostics

Hazard

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. · FDA Class II

Units

18,961 kits

Sold at

Worldwide distribution - US Nationwide.

Description

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Product

ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →