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Health Canada Health products

LIFECODES LSA Class II

Issued June 19, 2026
Issue
Product LIFECODES LSA Class II Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
Werfen has identified that two beads within the LIFECODES LSA class II assay kit(s) may present different DQB1 specificities than previously understood:• Bead 42 / Antigen ID 242Previously associated with DQB1*02:01, this bead instead presents DQB1*02:02• Bead 44 / Antigen ID 244Previously associated with DQB1*02:02, this bead instead presents DQB1*02:01• Note: DQA1*02:01 is present on both beads and therefore not impacted.Due to this issue, certain reactivity patterns may appear differently than expected.
Reference
ID
RA-82270