[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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 |
|---|---|
| Brand / manufacturer | Siemens Healthcare Diagnostics, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1505-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 March 2023 |
| EAN / barcode | 00630414602943 |
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 →
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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.