FDA Warns Against Use Of Needle-Free Devices With Dermal Fillers
The agency’s warning says that needle-free dermal filler “pens” sold on social media could pose a serious risk to consumers.
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Physicians on the panel backed suggestions including improved labeling, broadening the patient pool for clinical trials, and more thoroughly tracking adverse events.
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.