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Health Canada Medical devices

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

Issued August 21, 2024
Issue
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
Hazard description
Device compatibility
Product
Product name
ADVIA® and Atellica® Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Assay
Reference
ID
RA-75952