No image published for this recall

No image published for this recall

Alinity m system

Official notice

8 Apr 2024

Last checked

8 Apr 2024

Medium riskHealth Canada

An official Health Canada notice concerns Alinity m system. Abbott has identified an issue concerning the use of certain third-party universal transport medium (UTM) tubes on the Alinity M System. This issue has been observed with Copan® UTM-RT 3 mL without beads transport & preservation medium for viral molecular diagnostics testing, part number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue. Recall Start Date: March 22, 2024 Published 2024-04-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75361

Official notice

2024-04-08

The hazard

Abbott has identified an issue concerning the use of certain third-party universal transport medium (UTM) tubes on the Alinity M System. This issue has been observed with Copan® UTM-RT 3 mL without beads transport & preservation medium for viral molecular diagnostics testing, part number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue. Recall Start Date: March 22, 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.

Recall Numbers

75361

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Affected products

Product 1

Affected products - Alinity M System, Lot or serial number - All lots., Model or catalog number - 08N53-002

Risk / hazard

Abbott has identified an issue concerning the use of certain third-party universal transport medium (UTM) tubes on the Alinity M System. This issue has been observed with Copan® UTM-RT 3 mL without beads transport & preservation medium for viral molecular diagnostics testing, part number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue. Recall Start Date: March 22, 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

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Molecular, Alinity M System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75361

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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