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Manufacturers
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
Source
USFDA
14 Events
Recall of Device Recall COBAS INTEGRA Creatinine Jaffe
Recall of Device Recall PO2 electrode
Recall of Device Recall CoaguChek Pro DM System
Recall of Device Recall CoaguChek Plus
Recall of Device Recall CoaguChek test strips
Recall of Device Recall Modular P
Recall of Device Recall MagNA Pure LC
Recall of Device Recall MagNA Pure
Recall of Device Recall Dahedi
Recall of Elecsys Troponin T
Recall of Elecsys Troponin T STAT
Recall of Roche/Hitachi Tina-quant RF II
Recall of Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
Recall of CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].
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14 devices in the database
Device Recall COBAS INTEGRA Creatinine Jaffe
Model / Serial
lot 639106
Distribution
United States
Product Description
COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
Device Recall PO2 electrode
Model / Serial
All PO2 electrodes are affected.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Distribution
United States
Product Description
PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
Device Recall CoaguChek Pro DM System
Model / Serial
All units.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
Device Recall CoaguChek Plus
Model / Serial
All units
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
CoaguChek Plus meter; catalog # 475729 and 12816001.
Device Recall CoaguChek test strips
Model / Serial
lot 533
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Germany
Product Description
CoaguChek PT test strips, sold in 12 pack.
9 more
2 manufacturers with a similar name
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Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA
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