Miseqdx Cystic Fibrosis 139-variant Assay (2018-02-13)

MiSeqDx Cystic Fibrosis 139-Variant Assay Recall Illumina's MiSeqDx Cystic Fibrosis 139-Variant Assay, a genetic test used to detect cystic fibrosis mutations, has been recalled across Canada. The recall was issued because of issues with the medical device itself. This is a Class I recall, meaning there is a serious potential health risk, and the product was distributed throughout Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-02-22
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6ade950e-1e2c-48e8-80c5-cd7ae7210856