Drug recall
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes…
FDA recall event 70775 · Class II · Roche Diabetes Care, Inc.
Key facts
| Event ID | 70775 |
|---|---|
| Recall numbers | Z-1369-2015 |
| Recalling firm | Roche Diabetes Care, Inc. |
| Product type | Devices |
| Products | ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough… |
| Initiation date | Oct 30, 2014 |
| Report date | Apr 8, 2015 |
| Termination date | Jun 8, 2015 |
| 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: