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 3113160-00 3131030-00 808 216

Issue

A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a decrease in reactivity over their life of approximately nine months. Soon, the acceptance criteria may no longer be met. Therefore, these lots are also being recalled.

Recall start date: Mar 22, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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