MelaFind Device Recalled for Unapproved User Interface Data Display
MELA Sciences is recalling 65 MelaFind devices because the probability and histogram data displayed in the user interface lacks FDA approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a regulatory compliance issue regarding unapproved data display rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
MELA Sciences, Inc. is recalling 65 units of the MelaFind Device, Model MF 100 US, an optical diagnostic device used for melanoma detection. The recall is due to the fact that the probability and histogram data within the device's displayed user interface lacks approval and was not included in the Premarket Approval (PMA) supplement.
The affected devices were distributed to facilities in Alabama, California, Connecticut, Colorado, Florida, Hawaii, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and Washington. The specific UDI for the recalled units is *+M709MF100US0/$$+7DN0123MAS*.
Consumers and healthcare providers should stop using the affected MelaFind devices and contact MELA Sciences, Inc. for further instructions regarding the recall.
The recalled product
- Product
- MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
- Manufacturer
- MELA Sciences, Inc.
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI *+M709MF100US0/$$+7DN0123MAS*
Distribution
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