CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report
MelaFind Device recalled by MELA Sciences
MELA Sciences is recalling MelaFind Device, distributed in 21 states. The recall was initiated on 2 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1636-2015
- FDA event ID
- 71127
- Recalling firm
- MELA Sciences, Irvington, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2015
- FDA classified
- 20 May 2015
- Reported
- 27 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Apr 2015 | Recall initiated by company | |
| 20 May 2015 | Classified by FDA | +48 days |
| 27 May 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Product as listed by the FDA
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Where it was distributed
AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
AlabamaCaliforniaColoradoConnecticutFloridaHawaiiIllinoisMassachusettsMarylandMichiganNew HampshireNew JerseyNew YorkOhioPennsylvaniaRhode IslandSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Is MelaFind Device recalled?
Yes. MELA Sciences recalled MelaFind Device on 2 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1636-2015.
Why was it recalled?
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Which lots are affected?
UDI *+M709MF100US0/$$+7DN0123MAS*
Where was it sold?
AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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