Devices

Roche Online TDM Tobramycin

Model / Serial
Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
International Distribution ONLY-Australia, Canada and Germany.
Product Description
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)
Manufacturer
Roche Diagnostics Corp.
2 Events
- Recall of Roche Online TDM Tobramycin
- Recall of Roche Online TDM Tobramycin

Manufacturer

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
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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