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Biomerieux VITEK 2 Gram Negative test kits containing colistin (cs01n) - safety alert

Official notice

2 Aug 2017

MediumFDA

An official FDA notice concerns VITEK 2 Gram Negative test kits containing colistin (cs01n). The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2017-08-02. Recall numbers: Z-2770-2017. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,520,000

Recall number

Z-2770-2017

Official notice

2017-08-02

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.

Event Ids

77373

Recall Numbers

Z-2770-2017

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Affected products

Product 1

VITEK 2 Gram Negative test kits containing colistin (cs01n)

Units affected

1,520,000

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 · NC

Affected area 1

US · United States

Affected area 2

AR · Argentina

Affected area 3

AT · Austria

Affected area 4

BR · Brazil

Affected area 5

CA · Canada

Affected area 6

CL · Chile

Affected area 7

CN · China

Affected area 8

CO · Colombia

Affected area 9

CR · Costa Rica

Affected area 10

DE · Germany

Affected area 11

DO · Dominican Republic

Affected area 12

ES · Spain

Affected area 13

FR · France

Affected area 14

GB · United Kingdom

Affected area 15

GT · Guatemala

Affected area 16

HK · Hong Kong

Affected area 17

IL · Israel

Affected area 18

IN · India

Affected area 19

IT · Italy

Affected area 20

JP · Japan

Affected area 21

KR · South Korea

Affected area 22

MX · Mexico

Affected area 23

MY · Malaysia

Affected area 24

NL · Netherlands

Affected area 25

PE · Peru

Affected area 26

PL · Poland

Affected area 27

SG · Singapore

Affected area 28

TH · Thailand

Affected area 29

TR · Turkey

Affected area 30

UY · Uruguay

Affected area 31

VE · Venezuela

Affected area 32

VN · Vietnam

Affected area 33

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-2770-2017

Event id

77373

Units affected

1,520,000

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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