Quanta Flash Gbm Calibrators
Brand(s)
Last updated
Summary
Product
Quanta Flash Gbm Calibrators
Issue
Medical devices - Performance issue
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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