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Manufacturers
Roche Molecular Systems, Inc.
Manufacturer Address
Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
9 Events
Recall of Device Recall cobas Liat Analyzer
Recall of Device Recall Roche
Recall of Device Recall Roche Molecular Systems
Recall of Device Recall cobas Liat Analyzer
Recall of Device Recall cobas Liat Influenza A/B Quality Control Kit
Recall of Device Recall Roche Molecular Systems
Recall of Device Recall MagNA Pure 24 System Pathogen Protocols
Recall of Roche Molecular Diagnostics Inc.
Recall of Cobas
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9 devices in the database
Device Recall cobas Liat Analyzer
Model / Serial
Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the states of :TX and NC.
Product Description
cobas Liat Analyzer, for in vitro diagnostic use.
Device Recall Roche
Model / Serial
Material Number - IVD: 5401062001
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Hand-Held Scanner USB IT3800 || For sample identification and tracking when used with various systems
Device Recall Roche Molecular Systems
Model / Serial
EGFR v2: 07248563190 cfDNA: 07247737190
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Hungary
Product Description
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample || Preparation Hungarian Translation Instructions for Use
Device Recall cobas Liat Analyzer
Model / Serial
US-IVD: M1-E-00383 & M1-E-00434
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in NC and WA.
Product Description
cobas¿ Liat¿ Analyzer
Device Recall cobas Liat Influenza A/B Quality Control Kit
Model / Serial
Lot Numbers: 51222E, 60121H, 60201D, and 60229F
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
Product Description
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
4 more
8 manufacturers with a similar name
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Roche Molecular Systems, Inc.
Manufacturer Address
Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
Roche Molecular Systems, Inc.
Manufacturer Address
Roche Molecular Systems, Inc., 1080 US Highway 202 South, Somerville NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
Roche Molecular Systems, Inc.
Manufacturer Parent Company (2017)
Roche Holding AG
Source
SATP
Roche Molecular Systems, Inc.
Manufacturer Parent Company (2017)
Roche Holding AG
Source
SATP
Roche Molecular Systems, Inc.
Manufacturer Address
Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
Source
USFDA
3 more
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