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Official recall record

ADVIA® and Atellica® Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Assay

Health Canada — Medical Devices · 2024-08-21 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-08-21
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Siemens Healthineers has confirmed the potential for biased quality control (qc) and patient results when using Atellica® CH Urinary/Cerebrospinal Fluid Protein (UCFP) lot 130414 on the Stellica® CH and Stellica® CI analyzers. Siemens' internal investigation confirmed when using lot 130414, QC may recover outside of the allowable control limits for urine chemistry and spinal fluid control levels. Recall start date: August 1, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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