Device recall
Z-1077-2018: Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis…
FDA device recall · Class II · Epigenomics Ag
Key facts
| Recall number (Z-number) | Z-1077-2018 |
|---|---|
| Recall event | 79364 |
| Product | Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908; |
| Product code | PHP |
| Recalling firm | Epigenomics Ag |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2018 |
| PMA numbers | P130001 |
| FEI number | 3005968611 |
At a glance
- None 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