Devices

Device Recall Roche cobas

  • Model / Serial
    Material number 05985595190; Lot number R03607
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
  • Product Description
    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., || Product Usage: || The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event

Manufacturer

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

18 devices with a similar name

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Device Recall Roche cobas b 123 POC system
  • Model / Serial
    cobas b 123 Fluid Pack COOx Catalog 05169992001, lot numbers 21446113 (exp 8/8/2015), 21446123 (exp 8/18/2015), 21446153 ( exp 9/18/2015), 21446183 (exp 9/19/2015), and 21446203 (exp 10/01/2015)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
  • Product Description
    cobas b 123 Fluid Pack COOX REF 05169992001 200 || Product Usage: || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall Roche cobas b 123 POC system
  • Model / Serial
    cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
  • Product Description
    cobas b 123 Fluid Pack COOX REF 05170036001 400 || Product Usage: || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall Roche cobas p312 preanalytical system
  • Model / Serial
    Not applicable
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    cobas p 312 Pre-Analytical System || calculator/data processing module, for clinical use || Product Usage: || The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall Roche cobas p471 system
  • Model / Serial
    Not applicable
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    cobas p 471 centrifuge unit || calculator/data processing module, for clinical use || Product Usage: || The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall Roche COBAS INTEGRA 800 /800 CTS Analyzer, Analyzer,
  • Model / Serial
    Not applicable
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Roche COBAS INTEGRA 800 /800 CTS Analyzer || Analyzer, Chemistry (Photometric, Discrete for Clinical use || Product Usage: || The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
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