ADVIA® and Atellica® Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Assay
Brand(s)
Last updated
Summary
Product
ADVIA® and Atellica® Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Assay
Issue
Medical devices - Device compatibility
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| ADVIA® Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Assay | 140 | 11319151 11097543 |
| Atellica® CH Urinary/Cerebrospinal Fluid Protein (UCFP) | 130414 | Not applicable. |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Chemistry
Companies
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave, Tarrytown, New York, United States, 10591
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-75952
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