Device recall
Z-1783-2010: Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical…
FDA device recall · Class II · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-1783-2010 |
|---|---|
| Recall event | 54630 |
| Product | Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood. |
| Product code | CGA |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2011 |
| 510(k) numbers | K060345, K063821, K070960 |
| FEI number | 1219029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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