Drug recall
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
FDA recall event 71127 · Class II · MELA Sciences, Inc.
Key facts
| Event ID | 71127 |
|---|---|
| Recall numbers | Z-1636-2015 |
| Recalling firm | MELA Sciences, Inc. |
| Product type | Devices |
| Products | MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement). |
| Initiation date | Apr 2, 2015 |
| Report date | May 27, 2015 |
| Termination date | May 4, 2016 |
| City | Irvington |
| State | NY |
| Country | United States |
| FEI number | 3002112549 |
At a glance
- 1–9 Products in this recall
- None 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: