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Ortho optix reader

Official notice

13 Feb 2025

Last checked

13 Feb 2025

Medium riskHealth Canada

An official Health Canada notice concerns Ortho optix reader. There is an issue where mixed field (MF) grade error codes may not be generated on the Ortho Optix™ Reader as required by the software. Recall Start Date: January 31, 2025 Published 2025-02-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76945

Official notice

2025-02-13

The hazard

There is an issue where mixed field (MF) grade error codes may not be generated on the Ortho Optix™ Reader as required by the software. Recall Start Date: January 31, 2025

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

76945

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Affected products

Product 1

Affected products - Ortho Optix Reader, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 6842222

Risk / hazard

There is an issue where mixed field (MF) grade error codes may not be generated on the Ortho Optix™ Reader as required by the software. Recall Start Date: January 31, 2025

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: Ortho-clinical Diagnostics, Ortho Optix Reader.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76945

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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