Recall Z-2765-2019— Roche Diabetes Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2017-06-12, terminated 2020-10-30. It names one FDA 510(k) clearance: K133862. Product: Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring 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 Accu-Chek Aviva Plus Blood Glucose Monitoring 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). c. 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.. Reason: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on)..
- Recalling firm
- Roche Diabetes Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-12
- Terminated
- 2020-10-30
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring 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 Accu-Chek Aviva Plus Blood Glucose Monitoring 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). c. 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.
Reason for recall
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Data sourced from openFDA. This site is unofficial and independent of the FDA.