Monoclonal Mouse Anti-pneumocystis Jiroveci, Clone 3f6 And Monoclonal Mouse Ant-human Leukemia, Hairy Cell Clone Dba.44 (2018-03-23)

Recall Summary Two monoclonal antibody products—Monoclonal Mouse Anti-Pneumocystis Jiroveci (Clone 3F6) and Monoclonal Mouse Anti-Human Leukemia, Hairy Cell (Clone DBA.44)—are being recalled across Canada. These laboratory diagnostic reagents were recalled because they are classified as medical devices requiring proper regulatory approval. The recall affects all supplies of these products that were distributed throughout Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-04-24

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ac3d490f-1056-42f7-81ea-cd9d8f792ee9