Simplexa Direct Detection Pcr Assays (2016-02-10)

Simplexa Direct Detection PCR Assays Recall Simplexa Direct Detection PCR Assays, which are laboratory diagnostic tests used to detect certain infections, are being recalled across Canada. The devices were recalled due to issues classified as a Class I medical device problem. This recall affects healthcare facilities and laboratories that use these assays.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2016-03-10
Status
Closed
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/732a6194-3512-4d87-b3ef-7a87288c80a3