LIFECODES LSA Class II
Brand(s)
Last updated
Summary
Product
LIFECODES LSA Class II
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| LIFECODES LSA Class II | 3016850 | 265200IVD |
| LIFECODES LSA Class II | 3016697 | 265200IVD |
| LIFECODES LSA Class II | 3016317 | 265200IVD |
| LIFECODES LSA Class II | 3016532 | 265200IVD |
| LIFECODES LSA Class II | 3016100 | 265200IVD |
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 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
| Immucor Gti Diagnostics, Inc. |
| 20925 Crossroads Circle, Waukesha, Wisconsin, United States, 53186 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82270
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