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Roche Diagnostics Operations BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 - safety alert

Official notice

14 Oct 2020

Last checked

14 Oct 2020

Medium riskFDA

An official FDA notice concerns Roche Diagnostics Operations BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 - safety alert. An official FDA notice concerns BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2020-10-14. Recall numbers: Z-0085-2021. Check the official notice for the complete list. Published 2020-10-14.

What to do now

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

Units affected

2,623

Recall number

Z-0085-2021

Official notice

2020-10-14

The hazard

An official FDA notice concerns BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2020-10-14. Recall numbers: Z-0085-2021. 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

86399

Recall Numbers

Z-0085-2021

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Affected products

Product 1

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Units affected

2,623

Risk / hazard

An official FDA notice concerns BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2020-10-14. Recall numbers: Z-0085-2021. 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 · 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-0085-2021

Event id

86399

Units affected

2,623

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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