Health product recall

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