Devices

Device Recall Roche

제조사

Roche Diagnostics Corp.
  • 제조사 주소
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA

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Device Recall Roche Molecular Diagnostics
  • 모델명 / 제조번호(시리얼번호)
    Lots T10786 T13091, T15435, T15475, T14777, and W00389
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Foreign Distributed.
  • 제품 설명
    cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. || Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall Roche Molecular Diagnostics Inc.
Device Recall Roche cobas b 123 POC system
  • 모델명 / 제조번호(시리얼번호)
    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)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
  • 제품 설명
    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
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