Simplexa Direct Amplification Disc Kit

Recall Summary The Simplexa Direct Amplification Disc Kit, a diagnostic test product, is being recalled across Canada because it does not work as intended. This is a Class I recall, which means the product poses a serious health risk due to its inability to provide reliable test results. The product was distributed throughout Canada.

Product
Simplexa Direct Amplification Disc Kit
Reason
Lack of efficacy
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2021-12-13
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/8e240939-3193-4e1a-ace2-f6f6091cb48f