Health product recall

Anti-GM1 Autoantibodies Elisa IVD Test

Last updated

Summary

Product
Anti-GM1 Autoantibodies Elisa IVD Test
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Anti-GM1 Autoantibodies Elisa IVD Test

0461

EK-GM1-GM

Issue

Errancy of the microtiter plate of Anti-GM1 autoantibodies kit lot 0461 during production. False positive or false negative results may occur. Due to the production with non-validated microtiter plate, this risk can be increased with kit lot 0461. To prevent this risk, the kit must be removed from the market.

Recall start date: September 5, 2022

Additional information

Details
Original published date: 2022-09-26
Alert / recall type
Health product recall
Category
Health product - Medical device
Companies

Buhlmann Laboratories Ag

Baselstrasse 55, Schonenbuch, Switzerland, 4124

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64560