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Quanta flash gbm calibrators

Official notice

10 Feb 2023

Last checked

10 Feb 2023

Critical riskHealth Canada

An official Health Canada notice concerns Quanta flash gbm calibrators. As a result of an investigation of the above-mentioned lot, we have confirmed that the calibrator values assigned to this lot are erroneous. These erroneous value assignments would lead to an increase in patient values and could therefore lead to overestimation of patient results, and potentially a false positive result. Recall start date: January 30, 2023 Published 2023-02-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72675

Official notice

2023-02-10

The hazard

As a result of an investigation of the above-mentioned lot, we have confirmed that the calibrator values assigned to this lot are erroneous. These erroneous value assignments would lead to an increase in patient values and could therefore lead to overestimation of patient results, and potentially a false positive result. Recall start date: January 30, 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.

Lots

are

Recall Numbers

72675

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Affected products

Product 1

Affected products - Quanta Flash Gbm Calibrators, Lot or serial number - 223636, Model or catalog number - 701141

Risk / hazard

As a result of an investigation of the above-mentioned lot, we have confirmed that the calibrator values assigned to this lot are erroneous. These erroneous value assignments would lead to an increase in patient values and could therefore lead to overestimation of patient results, and potentially a false positive result. Recall start date: January 30, 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: Inova Diagnostics, Quanta Flash Gbm Calibrators.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

72675

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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