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Official recall record

Flowpra Class I And II Screening Tests

Health Canada — Medical Devices · 2024-06-20 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-06-20
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

A suspected false negative for HLA class I with FL1-30 lot 022. Complaint investigation testing was performed using 4 samples with low levels of A2 antibody specificities and 1 sample with low levels of A31 antibody specificities. Investigation confirmed a lower percentage of positive reactions for samples tested with FL1-30 lot 022. In addition, investigation noted that lot specific user document, TDX-OLI-DMR-LOT-8536 revision 01, has incorrect reference values for the distribution of certain HLA class I antigen specificities. Recall start date: May 29, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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