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Terminated

MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.

FDA Recall Z-1636-2015 · Posted 2015-05-20

Recalling FirmMELA Sciences, Inc.
Recall StatusTerminated
Product CodeOYD
Date Initiated2015-04-02
Date Terminated2016-05-04
Product Quantity65 units

Reason for Recall

The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).

Firm Action

The probability and histogram data within the Melafind's device displayed user interface is not included in the PMA supplement

Root Cause

Software design

Distribution Pattern

AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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