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MELA Sciences, Inc. recalls MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Recalled May 27, 2015 · FDA recall Z-1636-2015 · MELA Sciences
Hazard
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement). · FDA Class II
Units
65 units
Sold at
AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
Description
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Product
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Manufacturer(s)
MELA Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →