Reported May 27, 2015 · Terminated
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
MELA Sciences, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MELA Sciences, Inc. · 50 S Buckhout St Ste 1 · Irvington, NY · 10533-2204
Is this the product you have?
- MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
- Lot codes and dates
- UDI *+M709MF100US0/$$+7DN0123MAS*
- Amount recalled
- 65 units
Where it was sold
Why it was recalled
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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