Drug recall
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek…
FDA recall event 73253 · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 73253 |
|---|---|
| Recall numbers | Z-1172-2016 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to… |
| Initiation date | Feb 11, 2016 |
| Report date | Mar 23, 2016 |
| Termination date | May 30, 2017 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
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: