Simplexa Direct Amplification Disc Kit
Brand(s)
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
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