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Ortho vision analyzers

Official notice

9 Apr 2024

Last checked

9 Apr 2024

Medium riskHealth Canada

An official Health Canada notice concerns Ortho vision analyzers. Due to a wash protocol implementation discrepancy, there is potential for carry over of the Anti-S which may impact results of certain tests after pipetting Anti-S reagent. This issue is intermittent because several factors must interact across a series of events for the false positive to occur. The wash protocol will be updated in the next software release. Recall start date: March 21, 2024 Published 2024-04-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75367

Official notice

2024-04-09

The hazard

Due to a wash protocol implementation discrepancy, there is potential for carry over of the Anti-S which may impact results of certain tests after pipetting Anti-S reagent. This issue is intermittent because several factors must interact across a series of events for the false positive to occur. The wash protocol will be updated in the next software release. Recall start date: March 21, 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

75367

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Affected products

Product 1

Affected products - Ortho Vision Analyzer, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 6904577

Product 2

Affected products - Ortho Vision Max Analyzer, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 6904576

Risk / hazard

Due to a wash protocol implementation discrepancy, there is potential for carry over of the Anti-S which may impact results of certain tests after pipetting Anti-S reagent. This issue is intermittent because several factors must interact across a series of events for the false positive to occur. The wash protocol will be updated in the next software release. Recall start date: March 21, 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: Ortho-clinical Diagnostics, Ortho Vision Analyzers.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75367

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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