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Devices
Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
Model / Serial
All units.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
United States.
Product Description
Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
Language
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