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Simplexa direct amplification disc kit
Official notice
13 Dec 2021
Last checked
13 Dec 2021
An official Health Canada notice concerns Simplexa direct amplification disc kit. 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 Published 2021-12-13.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63711
Official notice
2021-12-13
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Product 2
Product 3
Product 4
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Diasorin Molecular, Simplexa Direct Amplification Disc Kit.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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