Recall Monitor
Health Products

LIFECODES LSA Class II

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: LIFECODES LSA Class II
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
LIFECODES LSA Class II3016850265200IVD
LIFECODES LSA Class II3016697265200IVD
LIFECODES LSA Class II3016317265200IVD
LIFECODES LSA Class II3016532265200IVD
LIFECODES LSA Class II3016100265200IVD

Issue

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.

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