FDA Device recall Z-2766-2019
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the qua…
- FDA Device
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the qua… by Roche Diabetes Care, citing meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2766-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-12 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diabetes Care |
| Distribution | US |
Product
Accu-Chek Performa 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).
Identifiers
| code_info | Serial numbers less than xxx25525056 Updated serial numbers on 10/12/2019: Performa II: Between XXX20000000 and XX…Serial numbers less than xxx25525056 Updated serial numbers on 10/12/2019: Performa II: Between XXX20000000 and XXX25525056 Updated 10/18/2019: Performa II: from XXX20000000 to XXX25525056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Roche Diabetes Care
- Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
FDA Device · Class II · 2024-07-03 · Roche Diabetes Care - RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
FDA Device · Class II · 2022-05-04 · Roche Diabetes Care - Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
All Roche Diabetes Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2766-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.