Public recall detail

Anti-GM1 Autoantibodies Elisa IVD Test

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Recall Safety notice
Quick summary

Quick summary: Anti-GM1 Autoantibodies Elisa IVD Test.

Recommended action

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Recall details

Quick summary: Anti-GM1 Autoantibodies Elisa IVD Test.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBuhlmann Laboratories Ag
ProductAnti-GM1 Autoantibodies Elisa IVD Test
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64560

Affected products

ProductAnti-GM1 Autoantibodies Elisa IVD Test
Lot0461
ModelEK-GM1-GM
Serial number0461
DescriptionAnti-GM1 Autoantibodies Elisa IVD Test

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices
CompaniesBuhlmann Laboratories Ag Baselstrasse 55, Schonenbuch, Switzerland, 4124
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64560
Background{}
CompaniesBuhlmann Laboratories Ag Baselstrasse 55, Schonenbuch, Switzerland, 4124
AudiencesHealthcare
Source updated2022-09-20

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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