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Biomerieux VIDAS¿ CMV IgM 30 Tests - safety alert

Official notice

21 Apr 2021

MediumFDA

An official FDA notice concerns VIDAS¿ CMV IgM 30 Tests. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2021-04-21. Lots: 1008143230, 1008143260. Recall numbers: Z-1408-2021. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

18,705

Recall number

Z-1408-2021

Official notice

2021-04-21

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

1008143230, 1008143260

Event Ids

87555

Recall Numbers

Z-1408-2021

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Affected products

Product 1

VIDAS¿ CMV IgM 30 Tests

Units affected

18,705

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

AR · Argentina

Affected area 3

AU · Australia

Affected area 4

BE · Belgium

Affected area 5

BG · Bulgaria

Affected area 6

BR · Brazil

Affected area 7

CH · Switzerland

Affected area 8

CL · Chile

Affected area 9

CO · Colombia

Affected area 10

CR · Costa Rica

Affected area 11

CZ · Czech Republic

Affected area 12

DE · Germany

Affected area 13

EG · Egypt

Affected area 14

ES · Spain

Affected area 15

FR · France

Affected area 16

GB · United Kingdom

Affected area 17

GR · Greece

Affected area 18

GT · Guatemala

Affected area 19

HK · Hong Kong

Affected area 20

HR · Croatia

Affected area 21

HU · Hungary

Affected area 22

IL · Israel

Affected area 23

IN · India

Affected area 24

IT · Italy

Affected area 25

JP · Japan

Affected area 26

KR · South Korea

Affected area 27

LT · Lithuania

Affected area 28

MT · Malta

Affected area 29

MX · Mexico

Affected area 30

NL · Netherlands

Affected area 31

PE · Peru

Affected area 32

PK · Pakistan

Affected area 33

PL · Poland

Affected area 34

PT · Portugal

Affected area 35

RO · Romania

Affected area 36

RS · Serbia

Affected area 37

SA · Saudi Arabia

Affected area 38

SE · Sweden

Affected area 39

SG · Singapore

Affected area 40

SI · Slovenia

Affected area 41

SV · El Salvador

Affected area 42

TH · Thailand

Affected area 43

TR · Turkey

Affected area 44

UY · Uruguay

Affected area 45

VN · Vietnam

Affected area 46

ZA · South Africa

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

medium

Recall details

Recall number

Z-1408-2021

Event id

87555

Units affected

18,705

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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