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Siemens Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000 - safety alert

Official notice

14 Jul 2021

Last checked

14 Jul 2021

Medium riskFDA

An official FDA notice concerns Siemens Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000 - safety alert. An official FDA notice concerns Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2021-07-14. Recall numbers: Z-2028-2021. Check the official notice for the complete list. Published 2021-07-14.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

123

Recall number

Z-2028-2021

Official notice

2021-07-14

The hazard

An official FDA notice concerns Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2021-07-14. Recall numbers: Z-2028-2021. Check the official notice for the complete list.

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

88056

Recall Numbers

Z-2028-2021

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Affected products

Product 1

Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

Units affected

123

Risk / hazard

An official FDA notice concerns Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2021-07-14. Recall numbers: Z-2028-2021. Check the official notice for the complete list.

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 · NY · Tarrytown

Affected area 1

US · United States · NY · Tarrytown

Affected area 2

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens. Contact: Siemens Healthcare Diagnostics, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2028-2021

Event id

88056

Units affected

123

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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