Anti-GM1 Autoantibodies Elisa IVD Test
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
Buhlmann Laboratories Ag
Baselstrasse 55, Schonenbuch, Switzerland, 4124
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64560
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