Z-1504-2023Class II

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

Name: Z-1504-2023 Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-03-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-03-16 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the... on 2023-03-16. FDA classified it as Class II and gives the reason as "There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1504-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-16
Posted: 2023-05-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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 code: JFT Fluorometric, Cortisol
Reason for recall: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated 3/17/23 was sent to customers. Actions to be Taken by the Customer Discontinue use of urine patient samples with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays until further notice. Customers may continue to use serum and plasma sample types with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. An additional Resolution Customer Notification letter dated 2/29/24 was sent to customers explaining an improvement to raw material specification that restores assay performance with urine samples. Customers are asked to follow the instructions for urine patient samples and urine cortisol QC as stated in the notification and if using products listed in the original field action notice continue following the guidance as stated in the Field Action Letter. Customers with any questions are to contact the Customer Care Center or local Siemens Healthineers technical support representative.
Quantity in commerce: 34,746 kits
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1504-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1504-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-05-03
Z-1505-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-05-03

Product code JFT

K142723Class IIADVIA Centaur Cortisol (COR) AssySiemens Healthcare Diagnostics, Inc. / cleared 2015-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)