Public recall detail

LIFECODES LSA Class II

2026-07-02

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Health products Health product recall
Quick summary

Quick summary: LIFECODES LSA Class II. Reason: Health product recall. Category: Health products. Date: 2026-07-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: LIFECODES LSA Class II. Reason: Health product recall. Category: Health products. Date: 2026-07-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandImmucor Gti Diagnostics, Inc.
ProductLIFECODES LSA Class II
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82270

Affected products

ProductLIFECODES LSA Class II
Lot3016850
Model265200IVD
Serial number3016850
DescriptionLIFECODES LSA Class II
ProductLIFECODES LSA Class II
Lot3016697
Model265200IVD
Serial number3016697
DescriptionLIFECODES LSA Class II
ProductLIFECODES LSA Class II
Lot3016317
Model265200IVD
Serial number3016317
DescriptionLIFECODES LSA Class II
ProductLIFECODES LSA Class II
Lot3016532
Model265200IVD
Serial number3016532
DescriptionLIFECODES LSA Class II
ProductLIFECODES LSA Class II
Lot3016100
Model265200IVD
Serial number3016100
DescriptionLIFECODES LSA Class II

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesImmucor Gti Diagnostics, Inc.20925 Crossroads Circle, Waukesha, Wisconsin, United States, 53186
Recall date2026-06-19
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82270
Background{}
CompaniesImmucor Gti Diagnostics, Inc.20925 Crossroads Circle, Waukesha, Wisconsin, United States, 53186
AudiencesHealthcare
Source updated2026-07-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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