MelaFind Device recall
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Why was MelaFind Device recalled?
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI *+M709MF100US0/$$+7DN0123MAS*
- Product
- MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
- Recalling firm
- MELA Sciences, Inc.
- Quantity
- 65 units
- Distribution
- AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
- Recall date
- May 27, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)