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Biomerieux - safety alert

Official notice

8 Aug 2018

MediumFDA

An official FDA notice concerns Biomerieux. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2018-08-08. Lots: 1006041520. Recall numbers: Z-2588-2018. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

5,429

Recall number

Z-2588-2018

Official notice

2018-08-08

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

1006041520

Event Ids

80087

Recall Numbers

Z-2588-2018

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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

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

BG · Bulgaria

Affected area 5

BR · Brazil

Affected area 6

CA · Canada

Affected area 7

CH · Switzerland

Affected area 8

CO · Colombia

Affected area 9

CR · Costa Rica

Affected area 10

CZ · Czech Republic

Affected area 11

DE · Germany

Affected area 12

EE · Estonia

Affected area 13

EG · Egypt

Affected area 14

ES · Spain

Affected area 15

FR · France

Affected area 16

GR · Greece

Affected area 17

GT · Guatemala

Affected area 18

HK · Hong Kong

Affected area 19

HU · Hungary

Affected area 20

IL · Israel

Affected area 21

IN · India

Affected area 22

IT · Italy

Affected area 23

JP · Japan

Affected area 24

KR · South Korea

Affected area 25

KW · Kuwait

Affected area 26

LT · Lithuania

Affected area 27

LV · Latvia

Affected area 28

MX · Mexico

Affected area 29

NL · Netherlands

Affected area 30

PK · Pakistan

Affected area 31

PL · Poland

Affected area 32

PT · Portugal

Affected area 33

RO · Romania

Affected area 34

RS · Serbia

Affected area 35

RU · Russia

Affected area 36

SA · Saudi Arabia

Affected area 37

SE · Sweden

Affected area 38

TH · Thailand

Affected area 39

TR · Turkey

Affected area 40

UA · Ukraine

Affected area 41

UY · Uruguay

Affected area 42

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-2588-2018

Event id

80087

Units affected

5,429

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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