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
  • 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
  • 1 Event

Manufacturer

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

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 496947, 497291, 497296, 497325
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
  • Product Description
    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 || Product Usage: || The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
  • Manufacturer
  • Model / Serial
    Lot 476605
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
  • Product Description
    Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 || Product Usage: || The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
  • Manufacturer
  • Model / Serial
    Lot 476340
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
  • Product Description
    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 || Product Usage: || The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
  • Manufacturer
  • Model / Serial
    Aviva meter serial numbers 52500000000 through 52510999999.
  • Product Classification
  • 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
  • Model / Serial
    Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999.
  • Product Classification
  • 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
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