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Delfia xpress

Official notice

1 Jan 2022

Last checked

1 Jan 2022

Critical riskHealth Canada

An official Health Canada notice concerns Delfia xpress. We have become aware that the measured analyte concentrations in occasional patient samples may be decreased with the affected Delfia Xpress kit lots. The issue may also cause failed results. Based on investigation the antifoam concentration of the tracers is incorrect at the end of the manufacturing series and therefore only certain tracer vials are affected by the issue. The issue may lead to occasional pipetting failures of the tracer during the assay procedure. Recall start date: 2021-12-17 Published 2022-01-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63781

Official notice

2022-01-01

The hazard

We have become aware that the measured analyte concentrations in occasional patient samples may be decreased with the affected Delfia Xpress kit lots. The issue may also cause failed results. Based on investigation the antifoam concentration of the tracers is incorrect at the end of the manufacturing series and therefore only certain tracer vials are affected by the issue. The issue may lead to occasional pipetting failures of the tracer during the assay procedure. Recall start date: 2021-12-17

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.

Recall Numbers

63781

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Affected products

Product 1

Affected Products - Delfia Xpress Free Hcgβ Kit, Lot or serial number - 1069101301 1069180401 1069184501 1069008101 1069090301, Model or catalog number - 6002-0010 6002-001C

Product 2

Affected Products - Delfia Xpress Papp-A Kit, Lot or serial number - 1068893801 1069077201 1069077101, Model or catalog number - 6003-002C 6003-0020

Risk / hazard

We have become aware that the measured analyte concentrations in occasional patient samples may be decreased with the affected Delfia Xpress kit lots. The issue may also cause failed results. Based on investigation the antifoam concentration of the tracers is incorrect at the end of the manufacturing series and therefore only certain tracer vials are affected by the issue. The issue may lead to occasional pipetting failures of the tracer during the assay procedure. Recall start date: 2021-12-17

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

Manufacturer

Not provided

Phone

Not provided

Brand: Wallac, Delfia Xpress.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

63781

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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