Device recall
Z-1854-2011: HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST…
FDA device recall · Class II · ITC-Nexus Dx, Inc.
Key facts
| Recall number (Z-number) | Z-1854-2011 |
|---|---|
| Recall event | 57773 |
| Product | HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated… |
| Product code | GKR |
| Recalling firm | ITC-Nexus Dx, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2012 |
| FEI number | 1000526865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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