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Biomerieux - safety alert

Official notice

30 Dec 2015

CriticalFDA

An official FDA notice concerns Biomerieux. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2015-12-30. Lots: 1004331500. Recall numbers: Z-0439-2016. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

5,458

Recall number

Z-0439-2016

Official notice

2015-12-30

The hazard

Infection risk

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

1004331500

Event Ids

72755

Recall Numbers

Z-0439-2016

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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

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BR · Brazil

Affected area 6

CA · Canada

Affected area 7

CH · Switzerland

Affected area 8

CL · Chile

Affected area 9

CO · Colombia

Affected area 10

CZ · Czech Republic

Affected area 11

DE · Germany

Affected area 12

EE · Estonia

Affected area 13

ES · Spain

Affected area 14

FR · France

Affected area 15

GB · United Kingdom

Affected area 16

HU · Hungary

Affected area 17

IL · Israel

Affected area 18

IN · India

Affected area 19

IT · Italy

Affected area 20

JP · Japan

Affected area 21

KW · Kuwait

Affected area 22

LT · Lithuania

Affected area 23

MY · Malaysia

Affected area 24

NL · Netherlands

Affected area 25

PK · Pakistan

Affected area 26

PL · Poland

Affected area 27

PT · Portugal

Affected area 28

RO · Romania

Affected area 29

RS · Serbia

Affected area 30

RU · Russia

Affected area 31

SA · Saudi Arabia

Affected area 32

SE · Sweden

Affected area 33

SG · Singapore

Affected area 34

TR · Turkey

Affected area 35

UY · Uruguay

Affected area 36

VE · Venezuela

Affected area 37

VN · Vietnam

Affected area 38

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Biomerieux. Contact: Biomerieux.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-0439-2016

Event id

72755

Units affected

5,458

Status

terminated

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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