ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA

FDA device recall Z-1505-2023 · posted 2023-05-03 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JFT

Quantity affected

18,961 kits

Distribution

Worldwide distribution - US Nationwide.

Date initiated

2023-03-16

Date posted

2023-05-03

Location

Tarrytown, NY

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