ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA
Summary
The FDA issued a Class II for ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 25 by Siemens Healthcare Diagnostics, Inc.. Reason: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low..
Details
Source
Device Recall
External ID
Z-1505-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 18,961 kits
Reason for Recall
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-16
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1505-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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