Device recall
Z-0820-2007: VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194…
FDA device recall · Class I · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0820-2007 |
|---|---|
| Recall event | 37873 |
| Product | VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK |
| Product code | MMI |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 7, 2012 |
| 510(k) numbers | K031031 |
| FEI number | 1000136573 |
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