Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ADVIA Centaur Cortisol 50T (Material Number 10994924) Recalled by Siemens Healthcare Diagnostics, Inc. Due to There is a negative bias with urine patient...

Date: March 16, 2023
Company: Siemens Healthcare Diagnostics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.

Affected Products

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.

Quantity: 18,961 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report