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Roche Diagnostics Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx - safety alert
Official notice
19 Apr 2017
Last checked
19 Apr 2017
An official FDA notice concerns Roche Diagnostics Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx - safety alert. An official FDA notice concerns Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx. The notice reports a chemical exposure risk. Follow the official notice for consumer instructions. Published 2017-04-19. Recall numbers: Z-1763-2017. Check the official notice for the complete list. Published 2017-04-19.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
45
Recall number
Z-1763-2017
Official notice
2017-04-19
The hazard
The hazard
An official FDA notice concerns Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx. The notice reports a chemical exposure risk. Follow the official notice for consumer instructions. Published 2017-04-19. Recall numbers: Z-1763-2017. Check the official notice for the complete list.
How to check if you're affected
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.
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Affected products
Product 1
Units affected
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Affected area 2
Company & contacts
Company & contacts
Brand: Roche Diagnostics. Contact: Roche Diagnostics Corporation.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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