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Simplexa direct amplification disc kit
Official notice
4 Jul 2023
Last checked
4 Jul 2023
An official Health Canada notice concerns Simplexa direct amplification disc kit. A recent internal investigation identified a specific set of Simplexa Direct Amplification Discs (Mol1455) lots produced with a specific lot of raw material are at potential risk of leaking when the disc is re-used multiple times with the assays Simplexa HSV 1&2 Direct Mol2150, Simplexa Bordetella Direct (Mol2750), and Simplexa VZV Direct (Mol3650). A total of 13 affected lots of Mol1455 were shipped and distributed in Canada. A total 15 customers running these assays have the affected disc lots. Recall start date: June 26, 2023 Published 2023-07-04.
What to do now
Review notice & return reply form, discard remaining inventory, and retest any sample with an error code.
Recall number
73893
Official notice
2023-07-04
The hazard
The hazard
A recent internal investigation identified a specific set of Simplexa Direct Amplification Discs (Mol1455) lots produced with a specific lot of raw material are at potential risk of leaking when the disc is re-used multiple times with the assays Simplexa HSV 1&2 Direct Mol2150, Simplexa Bordetella Direct (Mol2750), and Simplexa VZV Direct (Mol3650). A total of 13 affected lots of Mol1455 were shipped and distributed in Canada. A total 15 customers running these assays have the affected disc lots. Recall start date: June 26, 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
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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