Linity I Hiv Ag/ab Combo Calibrator (2021-02-10)

Summary Abbott Diagnostics is recalling ALINITY I HIV AG/AB Combo Calibrator products distributed across Canada because they may not perform accurately during HIV testing. This affects healthcare facilities and laboratories that use this calibration tool for their HIV testing equipment. The recall is classified as Class I, meaning there is a serious potential for health problems.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-02-19

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bf2fa80a-4340-4409-b2f6-0722216dc448