Dimension Vista System, Dimension Xpand System & Dimension Exl System - Total Bilirubin Assay (2020-02-21)

Recall Summary Abbott Diagnostics is recalling certain Total Bilirubin Assay reagents used with Dimension Vista, Dimension Xpand, and Dimension Exl laboratory analyzer systems across Canada due to a medical device issue. The affected reagents were distributed nationwide and have been classified as a Class I recall, indicating a serious safety concern. Healthcare facilities and laboratories using these specific systems should check their inventory against the recall details.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-04-24

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a3a3dc96-a7c9-4aa1-8318-463a05201af0