Device recall
Z-1743-2018: ZYMUTEST HIA MonoStria qualitative screening assay intended for the global…
FDA device recall · Class II · Hyphen BioMed
Key facts
| Recall number (Z-number) | Z-1743-2018 |
|---|---|
| Recall event | 79797 |
| Product | ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810 |
| Product code | LCO |
| Recalling firm | Hyphen BioMed |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2018 |
| 510(k) numbers | K071255 |
| FEI number | 3004434070 |
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