International Medical Devices Database

24 devices in the database

Device Recall Roche/Hitachi Modular P Module GMMI immunoassay 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 P Module GMMI immunoassay analyzer; Catalog number 03284549001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

Device Recall Roche/Hitachi Modular D 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 D Module GMMI clinical chemistry analyzer; Catalog number 03284522001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

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

Device Recall Roche/Hitachi Modular P800 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 P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

Device Recall Roche/Hitachi Modular D2400 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 D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

19 more

2 manufacturers with a similar name

Learn more about the data here

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
Source
USFDA

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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