Device recall
Z-0747-2007: VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0747-2007 |
|---|---|
| Recall event | 37528 |
| Product | VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK. |
| Product code | LOM |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2012 |
| PMA numbers | P000044 |
| FEI number | 3003722914 |
At a glance
- None 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