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Abbott Kg Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution - safety alert

Official notice

4 Dec 2019

MediumFDA

An official FDA notice concerns Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2019-12-04. Recall numbers: Z-0544-2020. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

3,271

Recall number

Z-0544-2020

Official notice

2019-12-04

The hazard

Health risk requiring medical assessment

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

83847

Recall Numbers

Z-0544-2020

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Affected products

Product 1

Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

Units affected

3,271

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

DE · Germany · Wiesbaden

Affected area 1

DE · Germany · Wiesbaden

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Kg. Contact: Abbott Gmbh & Co. KG.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0544-2020

Event id

83847

Units affected

3,271

Status

active

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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