Health product recall

Quanta Flash Gbm Calibrators

Last updated

Summary

Product
Quanta Flash Gbm Calibrators
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Quanta Flash Gbm Calibrators

223636

701141

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Inova Diagnostics Inc

9900 Old Grove Road, San Diego, California, United States, 92131

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72675

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