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Anti-gm1 autoantibodies elisa ivd test

Official notice

20 Sept 2022

Last checked

20 Sept 2022

Medium riskHealth Canada

An official Health Canada notice concerns Anti-gm1 autoantibodies elisa ivd test. 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 Published 2022-09-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64560

Official notice

2022-09-20

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

0461

Recall Numbers

64560

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Affected products

Product 1

Affected products - Anti-GM1 Autoantibodies Elisa IVD Test, Lot or serial number - 0461, Model or catalogue number - EK-GM1-GM

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Buhlmann Laboratories, Anti-gm1 Autoantibodies Elisa Ivd Test.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64560

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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