FDAClass IIMay 10, 2023

ADVIA Centaur Cortisol 50T recall

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

Why was ADVIA Centaur Cortisol 50T recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943; Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher; ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950; Kit Lot Numbers: 49742344 88319346 29108348 and higher; ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659; Kit Lot Numbers: 75474344 11352346 and higher

Product
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
18,961 kits
Distribution
Worldwide distribution - US Nationwide.
Recall date
May 10, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls