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Biomerieux - safety alert

Official notice

21 Nov 2018

MediumFDA

An official FDA notice concerns Biomerieux. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2018-11-21. Lots: Z019EA1LB. Recall numbers: Z-0443-2019. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

268

Recall number

Z-0443-2019

Official notice

2018-11-21

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

Z019EA1LB

Event Ids

81323

Recall Numbers

Z-0443-2019

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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 · CA

Location 2

US · United States · FL

Location 3

US · United States · GA

Location 4

US · United States · MD

Location 5

US · United States · MI

Location 6

US · United States · MN

Location 7

US · United States · NC

Location 8

US · United States · NJ

Location 9

US · United States · NM

Location 10

US · United States · NY

Location 11

US · United States · OH

Location 12

US · United States · OR

Location 13

US · United States · RI

Location 14

US · United States · SC

Location 15

US · United States · TN

Location 16

US · United States · TX

Location 17

US · United States · VA

Location 18

US · United States · WA

Location 19

US · United States · WI

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

AU · Australia

Affected area 4

BE · Belgium

Affected area 5

CH · Switzerland

Affected area 6

CO · Colombia

Affected area 7

DE · Germany

Affected area 8

EE · Estonia

Affected area 9

ES · Spain

Affected area 10

FR · France

Affected area 11

GB · United Kingdom

Affected area 12

IL · Israel

Affected area 13

IN · India

Affected area 14

IT · Italy

Affected area 15

JP · Japan

Affected area 16

NL · Netherlands

Affected area 17

PT · Portugal

Affected area 18

SE · Sweden

Affected area 19

SG · Singapore

Affected area 20

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-0443-2019

Event id

81323

Units affected

268

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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