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Biomerieux VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit - safety alert

Official notice

19 Feb 2020

CriticalFDA

An official FDA notice concerns VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit. The notice reports a serious safety risk. Follow the official notice for consumer instructions. Published 2020-02-19. Lots: 1007410330. Recall numbers: Z-1107-2020. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,218

Recall number

Z-1107-2020

Official notice

2020-02-19

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

1007410330

Event Ids

84439

Recall Numbers

Z-1107-2020

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Affected products

Product 1

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

Units affected

1,218

Where it was sold

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

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Biomerieux. Contact: bioMerieux, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-1107-2020

Event id

84439

Units affected

1,218

Status

terminated

Classification

Class 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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