Device recall
Z-1365-06: ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1365-06 |
|---|---|
| Recall event | 35022 |
| Product | ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents include two Accu-Chek Advantage monitors including Cat. no. 2138018 and Cat. no. 2138026. Ref. nos. 12138018001 and 12218542001 both include include meters with model number 777. |
| Product code | LFR |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2008 |
| 510(k) numbers | K983047 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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