Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1504-2023)

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:

Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). 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-1504-2023

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: 34,746 kits

Code Information:

Atellica IM Cortisol (50T) UDI-DI: 00630414598659; Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and higher; Atellica IM Cortisol 250T UDI-DI: 00630414598642; Kit Lot Numbers: 50734343 88974345 29105347 and higher; Atellica IM Cortisol (REF) 250T UDI-DI: 00630414293608; Kit Lot Numbers: 53842343 58039343 94430345 and higher

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated