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 Go
Device Recall AccuChek Aviva
  • Model / Serial
    For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • Product Description
    Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall AccuChek Aviva
  • Model / Serial
    Aviva meter serial numbers 52500000000 through 52510999999.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • Product Description
    Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall AccuChek Aviva
  • Model / Serial
    Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • Product Description
    Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall AccuChek
  • Model / Serial
    All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.
  • Product Description
    Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).
  • Manufacturer
    Roche Diagnostics Corp.
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