Device recall
Z-0748-2020: Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL…
FDA device recall · Class II · Roche Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-0748-2020 |
|---|---|
| Recall event | 84119 |
| Product | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring… |
| Product code | NBW |
| Recalling firm | Roche Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2020 |
| FEI number | 3011393376 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database