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Advia® and atellica® chemistry urinary cerebrospinal fluid protein (ucfp) assay

Official notice

21 Aug 2024

MediumHealth Canada

An official Health Canada notice concerns Advia® and atellica® chemistry urinary cerebrospinal fluid protein (ucfp) assay. 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 Published 2024-08-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75952

Official notice

2024-08-21

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

130414, QC

Recall Numbers

75952

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Affected products

Product 1

Affected products - ADVIA® Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) Assay, Lot or serial number - 140, Model or catalog number - 11319151 11097543

Product 2

Affected products - Atellica® CH Urinary/Cerebrospinal Fluid Protein (UCFP), Lot or serial number - 130414, Model or catalog number - Not applicable.

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Siemens, Advia® And Atellica® Chemistry Urinary Cerebrospinal Fluid Protein Assay.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75952

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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