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Quanta flash gbm calibrators
Official notice
10 Feb 2023
Last checked
10 Feb 2023
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
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
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.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Inova Diagnostics, Quanta Flash Gbm Calibrators.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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