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[Recalled] 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 determinat

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductADVIA 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
Brand / manufacturerSiemens Healthcare Diagnostics, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1505-2023
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date16 March 2023
EAN / barcode00630414602943

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Healthcare Diagnostics, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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