Siemens Healthcare Diagnostics, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T ( due to There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026