HAEMONETICS MCS APHERESIS SYSTEM PROMOTION FOR UNAPPROVED USE
This article was originally published in The Gray Sheet
Executive Summary
HAEMONETICS MCS APHERESIS SYSTEM PROMOTION FOR UNAPPROVED USE is cited in a March 16 warning letter to the firm. The MCS mobile collection apheresis system, which is 510(k) cleared for platelet apheresis, is being promoted "for purposes for which it was never officially cleared and/or approved in violation of the Food, Drug and Cosmetic Act," FDA alleges. "Continued promotion, either written or verbal, could result in regulatory action without further notice," FDA warns.