FDA clearance for AS-5 Red Blood Cell filtration
Maco received clearance from the U.S. FDA for the filtration of AS-5 Red Blood Cells.
In the USA, three Red Blood Cell Additive Solutions are licensed. The LEUCOLAB LCG2 filter is now FDA cleared to be used on all three Additive Solutions.
Using a dockable filter has the potential to save Blood Centers from discarding a certain percentage of an expensive In-Line collection system, when the collection is discarded for production reasons, such as QNS draws, overdraws, testing discards etc.
The Leucolab LCG2 dockable system is FDA cleared for ALL Additive Solutions, giving Blood Centers the necessary flexibility to use whichever collection bag they desire, without having to go through the process of writing new SOPs, performing validations, and training staff when a different collection bag is used.
FDA has required all the latest cleared dockable filters to specify clearly in the Indications For Use with which Additive Solution that filter can be used. Not all Additive Solutions are the same.
UnitedPharma, the exclusive importer and distributor of Macopharma products in the USA, is proud to be able to now present the LEUCOLAB LCG2 Dockable Filter as the only filter specifically FDA cleared for use with AS-5 Red Blood Cells in the USA.