No image published for this recall

No image published for this recall

Roche Molecular cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190 - safety alert

Official notice

15 Feb 2023

Last checked

15 Feb 2023

Critical riskFDA

An official FDA notice concerns Roche Molecular cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190 - safety alert. An official FDA notice concerns cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2023-02-15. Recall numbers: Z-1104-2023. Check the official notice for the complete list. Published 2023-02-15.

What to do now

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

Units affected

18,071

Recall number

Z-1104-2023

Official notice

2023-02-15

The hazard

An official FDA notice concerns cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2023-02-15. Recall numbers: Z-1104-2023. 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 00875197006674

Event Ids

91482

Recall Numbers

Z-1104-2023

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Affected products

Product 1

cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

Units affected

18,071

Risk / hazard

An official FDA notice concerns cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2023-02-15. Recall numbers: Z-1104-2023. 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 · NJ · Branchburg

Affected area 1

US · United States · NJ · Branchburg

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Roche Molecular. Contact: Roche Molecular Systems, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-1104-2023

Event id

91482

Units affected

18,071

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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