Roche Accu-Chek Aviva Test Strips Recalled for Dosing Issues
Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in treatment decisions due to inability to obtain results, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diabetes Care, Inc. is recalling 61,329 units of ACCU-CHEK AVIVA ASPAC STRIP 50CT (Catalog Number: 06453970020, Lot Number: 498287). These test strips are intended for use with the Blood Glucose Monitoring System. The recall was initiated because the test strips may be unable to dose properly.
The inability to dose the test strips may result in a temporary inability to obtain a blood glucose result. This issue could lead to a delay in treatment and/or therapy decisions for patients relying on the device. The affected units were distributed nationwide and in foreign markets, including Australia and India.
Consumers who have these specific test strips should stop using them and contact Roche Diabetes Care for further instructions or a replacement. Patients should consult their healthcare provider if they are unable to obtain blood glucose readings.
The recalled product
- Product
- ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 61,329
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 498287
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Roche Diabetes Care, Inc.
See all →- HighBlood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units
FDA (Devices) · 2024-07-03
- HighDiabetes Management Software May Display Wrong Patient Data
FDA (Devices) · 2022-05-04
- HighAccu-Chek Performa Test Strips Recalled Due to Defective Packaging
FDA (Devices) · 2021-09-01
- HighAccu-Chek SmartView Test Strips May Open During Shipment
FDA (Devices) · 2021-09-01
- HighAccu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
FDA (Devices) · 2021-09-01
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighRoche Recalls Accu-Chek Aviva Plus Test Strips Due to Potential Errors
FDA (Devices) · 2018-06-20
- HighAccu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
FDA (Devices) · 2021-09-01
- HighRoche Recalls ACCU-CHEK Aviva Combo Blood Glucose Meters
FDA (Devices) · 2013-12-04
- HighRoche Recalls Accu-Chek Performa Test Strips Due to Potential Measurement Errors
FDA (Devices) · 2018-06-20
- ModerateRoche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor
FDA (Devices) · 2019-10-09
- HighRoche Recalls Accu-Chek Inform II Test Strips Due to Potential Errors
FDA (Devices) · 2018-06-20