Health product recall

Simplexa Covid-19 Direct Assay

Last updated

Summary

Product
Simplexa Covid-19 Direct Assay
Issue
Medical devices » Manufacturing defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Simplexa Covid-19 Direct Assay

12501N, 11269N, 13183N, 12348N, 11784N

MOL4150

Issue

It was recently internally identified that five (5) lots of Simplexatm COVID-19 direct (Ref MOL4150) were shipped to Canada that had been manufactured with the recombinant hot start polymerase produced by Diasorin S.P.A. instead of the enzyme from an external supplier. While the validation for the material made by Diasorin S.P.A. had been successfully completed, the change had not yet been approved by Health Canada for use in products shipped to Canada patient results are not impacted by this compliance related issue.

Recall start date: Jan 7, 2022

Additional information

Details
Original published date: 2022-01-13
Alert / recall type
Health product recall
Category
Health product » Medical device
Companies
Diasorin Molecular LLC

11331 Valley View Street, Cypress, California

United States, 90630

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63807