Device recall
Z-1742-2018: ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a…
FDA device recall · Class II · Hyphen BioMed
Key facts
| Recall number (Z-number) | Z-1742-2018 |
|---|---|
| Recall event | 79797 |
| Product | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use. |
| 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