Z-2765-2019Class II

Accu-Chek Aviva II Meter -

Name: Z-2765-2019 Accu-Chek Aviva II Meter -
Creator: Roche Diabetes Care, Inc.
Published: 2017-06-12
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2017-06-12 / Terminated

FDA source

Roche Diabetes Care, Inc. began a recall of 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... on 2017-06-12. FDA classified it as Class II and gives the reason as "Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2765-2019
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2019-09-30
Terminated: 2020-10-30
Recalling firm: Roche Diabetes Care, Inc.
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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
FDA root cause: Process change control
Action: In a Quality Notification dated December 19, 2018, the firm informed its distribution centers of the issue. Contact Centers were provided with updated troubleshooting guides for Aviva II and Performa II meters in August 2018 with instructions for phone solving power issues for meters produced between June 2016 and June 2017. The firm has taken corrective actions to address the issue. Customers should contact Accu-Chek Customer Care line at 1-800-358-4866, Monday through Friday, between the hours of 8:00 am and 8:00 pm Eastern Standard Time
Quantity in commerce: 26,600
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: Serial numbers between xxx20000000 and xxx23284925, or less than xxx06335297 Updated serial numbers on 10/12/2019: Aviva II: Between XXX20000000 and XXX23284925 Updated 10/18/2019: Aviva II from XXX05000001 to XXX06335297 OR from XXX20000000 to XXX23284925

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2765-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2765-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2766-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-30

Product code NBW

K133862Class IIAccu-Chek Aviva Plus SystemRoche Diagnostics Corporation / cleared 2014-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)