Aptima® CMV Quant Assay
Brand(s)
Last updated
Summary
Product
Aptima® CMV Quant Assay
Issue
Medical devices - Performance issue
What to do
Instructions provided on how to respond.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Aptima® CMV Quant Assay |
Contact the manufacturer. |
PRD-05074 |
Issue
When processing specific patient plasma specimens with the Aptima® CMV Quant Assay, a ML2 error flag may occur, which will invalidate specimens within the assay run.
Recall start date: November 20, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Immunology
Companies
Hologic, Inc.
10210 Genetic Center Drive, San Diego, California, United States, 92121
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74705
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