Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1505-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 16, 2023

Date Posted: May 10, 2023

Recall Number: Z-1505-2023

Event ID: 92059

Reason for Recall:

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

Status: Ongoing

Product Quantity: 18,961 kits

Code Information:

ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943; Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher; ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950; Kit Lot Numbers: 49742344 88319346 29108348 and higher; ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659; Kit Lot Numbers: 75474344 11352346 and higher

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated