Devices

Device Recall Roche/Hitachi Modular E Module GMMI clinical chemistry analyzer

Model / Serial
All units with software version 08-02.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
Product Description
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
Manufacturer
Roche Diagnostics Corp.
1 Event
- Recall of Device Recall Roche/Hitachi Modular E Module GMMI clinical chemistry analyzer

Manufacturer

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
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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