The federal safety watchdog said the probability and histogram data displayed on the Melafind’s user interface was not included in a PMA supplement.
The FDA posted the May 20 filing on its website yesterday. Sixty-five MelaFind units are covered in the recall.
MelaFind is an optical diagnostic system designed to identify and diagnose potential melanoma and provide a software-based imaging analysis of pigmented skin lesions to help determine biopsy necessity.
MELA shares closed down -3.1% at $1.54 apiece yesterday.