Anti-Lua (Lu1)
Brand(s)
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 |
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: 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