Mela Sciences (NSDQ:MELA) recalled its flagship MelaFind melanoma diagnosis aid because some of its software wasn’t included in its pre-market approval from the FDA.
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 Sciences won CE Mark approval for the device in the European Union and pre-market approval in the U.S. in 2011.
MELA shares closed down -3.1% at $1.54 apiece yesterday.