Device Recall ACCUCHEK Aviva Nano Blood Glucose Meter

05075572002, 05075599002, 05075602002, 05075629002, Part numbers: 05180848002, 05075246002, 05075530002, 05075548002, 05075556002, 05075564002 these are not finished device part numbers and were not intended for use in the US.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution-USA (nationwide) including the states of AZ, NY, RI, TN, NJ, IN, TX, AL, NV, CA, OR, KY, IL, AR, NM, NE, MD, MO, GA, and SD.

ACCU-CHEK Aviva Nano Blood Glucose Meter || No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. || The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).