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Health Canada Medical devices

Quanta Flash Gbm Calibrators

Issued February 10, 2023
Issue
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
Hazard description
Performance
Product
Product name
Quanta Flash Gbm Calibrators
Reference
ID
RA-72675