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Vanadis core t21 t18 t13 reagent cartridge

Official notice

18 Aug 2023

MediumHealth Canada

An official Health Canada notice concerns Vanadis core t21 t18 t13 reagent cartridge. Affected lots can include plates, which are slightly higher than normally, and the plates may rest higher on the instrument adapter (plates manufactured by our supplier using a different mold). This may result in run failure due to issues with moving the plate within the instrument or, due to suboptimal temperature during extraction of cell-free DNA, can cause insufficient protein degradation, which can potentially affect performance of the Vanadis Core® T21/T18/T13 reagent cartridge 3222-001B_CA. Recall Start Date: August 3, 2023 Published 2023-08-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74118

Official notice

2023-08-18

The hazard

Affected lots can include plates, which are slightly higher than normally, and the plates may rest higher on the instrument adapter (plates manufactured by our supplier using a different mold). This may result in run failure due to issues with moving the plate within the instrument or, due to suboptimal temperature during extraction of cell-free DNA, can cause insufficient protein degradation, which can potentially affect performance of the Vanadis Core® T21/T18/T13 reagent cartridge 3222-001B_CA. Recall Start Date: August 3, 2023

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

74118

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Affected products

Product 1

Affected products - Vanadis Core T21/T18/T13 Reagent Cartridge, Lot or serial number - 746100 745859 745619 744592 742254 745232 746522 741096 744481 744811 746077 743926 745136 744491, Model or catalog number - 3222-001B_CA

Risk / hazard

Affected lots can include plates, which are slightly higher than normally, and the plates may rest higher on the instrument adapter (plates manufactured by our supplier using a different mold). This may result in run failure due to issues with moving the plate within the instrument or, due to suboptimal temperature during extraction of cell-free DNA, can cause insufficient protein degradation, which can potentially affect performance of the Vanadis Core® T21/T18/T13 reagent cartridge 3222-001B_CA. Recall Start Date: August 3, 2023

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, Vanadis Core T21 T18 T13 Reagent Cartridge.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74118

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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