MELA Sciences, Inc. recalls MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
- Recall date
- April 2, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1636-2015
- FDA classification
- Class II
- Brand / firm
- MELA Sciences, Inc.
- Sold / distributed
- AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
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