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Simplexa covid-19 direct
Official notice
9 Feb 2023
Last checked
9 Feb 2023
An official Health Canada notice concerns Simplexa covid-19 direct. Customer complaints were received for disc leaks while running Simplexa Covid-19 Direct kit with assay definition version 2 (high spin & temp). Leakage was confirmed by retain testing on 1/6/22 with discs run on Covid-19 Direct assay definition version 2. No disc leakage occurred with version 3 (reduced spin & temp). Simplexa Flu A/B & RSV (mol2655) and Simplexa Covid-19 & Flu A/B Direct (mol4250) have similar assay definitions and are also at risk for leakage. Recall start date: February 01, 2023 Published 2023-02-09.
What to do now
Discontinue using remaining inventory, share recall notice with users, complete/return response form.
Recall number
72669
Official notice
2023-02-09
The hazard
The hazard
Customer complaints were received for disc leaks while running Simplexa Covid-19 Direct kit with assay definition version 2 (high spin & temp). Leakage was confirmed by retain testing on 1/6/22 with discs run on Covid-19 Direct assay definition version 2. No disc leakage occurred with version 3 (reduced spin & temp). Simplexa Flu A/B & RSV (mol2655) and Simplexa Covid-19 & Flu A/B Direct (mol4250) have similar assay definitions and are also at risk for leakage. Recall start date: February 01, 2023
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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Turn on recall alertsAffected products
Affected products
Product 1
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
Brand: Diasorin Molecular, Simplexa Covid-19 Direct.
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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