Drug recall
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is…
FDA recall event 83574 · Class II · Roche Diabetes Care, Inc.
Key facts
| Event ID | 83574 |
|---|---|
| Recall numbers | Z-2765-2019, Z-2766-2019 |
| Recalling firm | Roche Diabetes Care, Inc. |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). |
| Initiation date | Jun 12, 2017 |
| Report date | Oct 9, 2019 |
| Termination date | Oct 30, 2020 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 3011393376 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: