Devices

Device Recall AccuChek

  • Model / Serial
    Lots 31097UF, 3C135UF, 3D001UF, 3E008UF, 3E065UF, 3G012UF, 3G107UF, 3G116UF, 3H040UF, 3H051UF, 3J018UF, 3K035UF, 3K101UF, 3L098UF, 3L122UF, 4A127UF, 4D030UF, 4D032UF, 4D161UF, 4D180UF, 4F020UF, 4F083UF, 4G184UF, 4H101IF, 4K133UF and 4L096UF.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
  • Product Description
    Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001.
  • Manufacturer
    Disetronic Medical Systems, Inc.
  • 1 Event

Manufacturer

Disetronic Medical Systems, Inc.
  • Manufacturer Address
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

73 devices with a similar name

Learn more about the data here

Device Recall ACCUCHEK
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
  • Product Description
    ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents include two Accu-Chek Advantage monitors including Cat. no. 2138018 and Cat. no. 2138026. Ref. nos. 12138018001 and 12218542001 both include include meters with model number 777.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall ACCUCHEK Advantage
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
  • Product Description
    ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with meter model no. 3288650.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall ACCUChek Voicemate
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
  • Product Description
    ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English language version for the blind or visually impaired, Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall ACCUCHEK Voicemate
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
  • Product Description
    ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version for the blind or visually impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no. 768.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall ACCUCHEK
  • Model / Serial
    All lots expiring before July 31, 2007.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Paraguay, Peru, Philippines, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand and Uruguay.
  • Product Description
    Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 04647696001 and 04535120001.
  • Manufacturer
    Roche Diagnostics Corp.
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