No image published for this recall

No image published for this recall

Vitros® systems

Official notice

31 Oct 2023

Last checked

31 Oct 2023

Medium riskHealth Canada

An official Health Canada notice concerns Vitros® systems. After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. This monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems listed above, these systems may experience an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a 'screen freeze'), and/or printer disconnections. Recall start date: October 11, 2023 Published 2023-10-31.

What to do now

Review notice, save/post notice by each system until issues resolved, complete/return response form.

Recall number

74504

Official notice

2023-10-31

The hazard

After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. This monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems listed above, these systems may experience an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a 'screen freeze'), and/or printer disconnections. Recall start date: October 11, 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

74504

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Affected products

Product 1

Affected products - VITROS® XT 3400 Chemistry System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 684 4458

Product 2

Affected products - VITROS® XT 7600 Integrated System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 684 4461

Risk / hazard

After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. This monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems listed above, these systems may experience an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a 'screen freeze'), and/or printer disconnections. Recall start date: October 11, 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: Ortho-clinical Diagnostics, Vitros®.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74504

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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