No image published for this recall

No image published for this recall

Roche Diagnostics Operations cobas e801 Immunoassay Analyzer - safety alert

Official notice

17 Aug 2022

Last checked

17 Aug 2022

Medium riskFDA

An official FDA notice concerns Roche Diagnostics Operations cobas e801 Immunoassay Analyzer - safety alert. An official FDA notice concerns cobas e801 Immunoassay Analyzer. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-08-17. Recall numbers: Z-1515-2022. Check the official notice for the complete list. Published 2022-08-17.

What to do now

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

Units affected

965

Recall number

Z-1515-2022

Official notice

2022-08-17

The hazard

An official FDA notice concerns cobas e801 Immunoassay Analyzer. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-08-17. Recall numbers: Z-1515-2022. 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.

Other

UDI-DI 07613336158456

Event Ids

90657

Recall Numbers

Z-1515-2022

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Affected products

Product 1

cobas e801 Immunoassay Analyzer

Units affected

965

Risk / hazard

An official FDA notice concerns cobas e801 Immunoassay Analyzer. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-08-17. Recall numbers: Z-1515-2022. 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 · IN · Indianapolis

Affected area 1

US · United States · IN · Indianapolis

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Roche Diagnostics Operations. Contact: Roche Diagnostics Operations, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-1515-2022

Event id

90657

Units affected

965

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

US
No image published for this recall

cobas infinity central lab, Material Number 07154003001 - safety alert

Critical riskFDA18 Jan 2023
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA27 Jan 2021
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA11 Sept 2019
US
No image published for this recall

a product listed in the official notice - safety alert

Critical riskFDA7 Dec 2016
US
No image published for this recall

a product listed in the official notice - safety alert

Critical riskFDA16 Nov 2016
US
No image published for this recall

a product listed in the official notice - safety alert

Critical riskFDA12 Dec 2012
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA18 Dec 2019
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA25 Dec 2013
US
No image published for this recall

a product listed in the official notice - safety alert

Critical riskFDA24 Jul 2013
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA29 May 2013
US
No image published for this recall

a product listed in the official notice - safety alert

Low riskFDA30 Jan 2013
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA27 Nov 2024

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 17 Aug 2022. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.