Drug recall
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B…
FDA recall event 79364 · Class II · Epigenomics Ag
Key facts
| Event ID | 79364 |
|---|---|
| Recall numbers | Z-1077-2018 |
| Recalling firm | Epigenomics Ag |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The diagnostic test kit may produce invalid test runs which may delay test results. |
| Initiation date | Nov 2, 2017 |
| Report date | Mar 28, 2018 |
| Termination date | Jun 19, 2018 |
| City | Berlin |
| Country | Germany |
| FEI number | 3005968611 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: