Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1505-2023 — 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

U.S. FDA — Device Enforcement · United States · 2023-03-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1505-2023
Date of alert: 2023-03-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00630414602943

Reported risk: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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