ADVIA Centaur Cortisol 50T — Class II medical device recall Z-1505-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-05-10, distributed nationwide. There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermitte
| Recall number | Z-1505-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2023-03-16 |
| Classified | 2023-05-03 |
| Reported by FDA | 2023-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 18,961 kits |
| UPC / GTIN / UDI-DI | 00630414598659, 00630414602943, 00630414602950 |
| Lot numbers | 07241346, 11352346, 29108348, 29109348, 49741344, 49742344, 75474344, 88318346, 88319346 |
| Model numbers | 00630414598659, 11352346, 250T, 75474344 |
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 urine.
Reason for recall
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1505-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.