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Health Canada Medical devices

Simplexa Direct Amplification Disc Kit

Issued July 4, 2023
Issue
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
Hazard description
Performance
Product
Product name
Simplexa Direct Amplification Disc Kit
Reference
ID
RA-73893