Reported May 10, 2023 · Ongoing
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- 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 codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 0063041460294300630414602943 2 Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher 3 00630414602950ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950 4 Kit Lot Numbers: 49742344 88319346 29108348 and higher 5 00630414598659ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659 6 Kit Lot Numbers: 75474344 11352346 and higher - Amount recalled
- 18,961 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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