CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Accu-Chek Aviva Plus Retail Strips - intended recalled
Roche Diabetes Care is recalling Accu-Chek Aviva Plus Retail Strips - intended for Blood Glucose Monitoring System, distributed nationwide in the US. The recall was initiated on 11 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0998-2020
- FDA event ID
- 84518
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2019
- FDA classified
- 5 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 11 Dec 2019 | Recall initiated by company | |
| 5 Feb 2020 | Classified by FDA | +56 days |
| 12 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Where it was distributed
Nationwide: Foreign: Austalia, India
Questions about this recall
Is Accu-Chek Aviva Plus Retail Strips - intended for Blood Glucose Monitoring System recalled?
Yes. Roche Diabetes Care recalled Accu-Chek Aviva Plus Retail Strips - intended for Blood Glucose Monitoring System on 11 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-0998-2020.
Why was it recalled?
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Which lots are affected?
Lot Number:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7
Where was it sold?
Nationwide: Foreign: Austalia, India
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roche Diabetes Care
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accu-Chek Guide (SC) Kit -Intended to quantitatively recalled | Roche Diabetes Care | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | RocheDiabetes Care Platform recalled | Roche Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
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| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |