Health product recall

Simplexa Direct Amplification Disc Kit

Last updated

Summary

Product
Simplexa Direct Amplification Disc Kit
Issue
Medical devices - Lack of efficacy
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Simplexa Direct Amplification Disc Kit 13652N MOL1455
Simplexa Direct Amplification Disc Kit 13369N MOL1455
Simplexa Direct Amplification Disc Kit 12603N MOL1455
Simplexa Direct Amplification Disc Kit 12889N MOL1455

Issue

A recent internal investigation revealed that a subset of Simplexa Direct Amplification Discs (Ref MOL1455) are at risk of leakage when the disc is used more than one time with Simplexa Covid-19 direct and/or Simplexa flu A/B & RSV Direct Gen II. The predicted risk of leakage has been determined to be very low (0.0045%)

Recall start date: Nov 19, 2021

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
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-63711