Device recall
Z-0030-2012: Minutex D-Dimer; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1…
FDA device recall · Class II · Tcoag Us, Incorporated
Key facts
| Recall number (Z-number) | Z-0030-2012 |
|---|---|
| Recall event | 59957 |
| Product | Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888, Web: www.trinitybiotech.com Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer. |
| Product code | GHH |
| Recalling firm | Tcoag Us, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2012 |
| 510(k) numbers | K920668 |
| FEI number | 3005261996 |
At a glance
- 1–9 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