Drug recall
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000…
FDA recall event 77635 · Class II · Roche Diabetes Care, Inc.
Key facts
| Event ID | 77635 |
|---|---|
| Recall numbers | Z-0197-2018 |
| Recalling firm | Roche Diabetes Care, Inc. |
| Product type | Devices |
| Products | Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in… |
| Initiation date | Jun 8, 2017 |
| Report date | Dec 13, 2017 |
| Termination date | Aug 6, 2018 |
| 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: