Ptima Hiv-1 Quant Assay (2020-12-15)

Aptima HIV-1 Quant Assay Recall Summary The Aptima HIV-1 Quant Assay, a medical device used to measure HIV-1 levels in blood, is being recalled across Canada due to a Class I safety issue. This recall affects healthcare facilities and laboratories that use this test. The specific problem with the device has not been detailed in this notice.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-01-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/850b08f7-21a1-4e43-86e7-a4f00b1a383d