Health product recall

Anti-Lua (Lu1)

Last updated

Summary

Product
Anti-Lua (Lu1)
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Anti-Lua (Lu1)

3131020-00
3131030-00

808 216

Issue

Bio-Rad Laboratories would like to inform you that our polyclonal blood grouping reagent Anti-Lua (LU1) (Catalogue number 808216, Lots 3131020-00 and 3131030-00) shows a decrease in reactivity with erythrocytes with low antigenicity. This may result in unexpected false negative results. Alloanti-Lua is not considered as a clinically relevant antibody and no transfusion reactions are reported. However, false negative results may lead to a transfusion mismatch leading to an immunization of the patient, or - if already immunized - to a transfusion reaction in patients with serious preconditions.

Recall start date: Mar 22, 2022

Additional information

Details
Original published date: 2022-04-07
Alert / recall type
Health product recall
Category
Health product - Medical device - Haematology
Companies

Bio-Rad Medical Diagnostics Gmbh

Industriestr.1, Dreieich

Germany, 63303

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64043