Devices

Device Recall Cobas 8100 bidirectional reformatter (BRF)

Model / Serial
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Product Description
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Manufacturer
Roche Diagnostics Corporation
1 Event
- Recall of Device Recall Cobas 8100 bidirectional reformatter (BRF)

Manufacturer

Roche Diagnostics Corporation

Manufacturer Address
Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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