CanadaLIFECODES LSA Class II assay kits (Immucor Gti Diagnostics, Inc.), model/catalogue 265200IVD, lots 3016850, 3016697, 3016317, 3016532 and 3016100 are affected. They were recalled because bead 42 (Antigen ID 242) presents DQB1*02:02 instead of DQB1*02:01 and bead 44 (Antigen ID 244) presents DQB1*02:01 instead of DQB1*02:02, which may change expected reactivity patterns; DQA1*02:01 is present on both and not impacted. Contact the manufacturer for additional information.
What's being recalled
Companies: Immucor Gti Diagnostics, Inc., 20925 Crossroads Circle, Waukesha, Wisconsin, United States, 53186.
How to identify it
Affected products: LIFECODES LSA Class II; Lot or serial number: 3016850; Model or catalogue number: 265200IVD
Affected products: LIFECODES LSA Class II; Lot or serial number: 3016697; Model or catalogue number: 265200IVD
Affected products: LIFECODES LSA Class II; Lot or serial number: 3016317; Model or catalogue number: 265200IVD
Affected products: LIFECODES LSA Class II; Lot or serial number: 3016532; Model or catalogue number: 265200IVD
Affected products: LIFECODES LSA Class II; Lot or serial number: 3016100; Model or catalogue number: 265200IVD
The hazard
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 242
Previously associated with DQB1*02:01, this bead instead presents DQB1*02:02
• Bead 44 / Antigen ID 244
Previously 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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)