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The US Food and Drug Administration (FDA) has cleared a label change for the Fenwal Amicus system, a cell-separation device, to allow for 7-day storage of platelets collected via this system.
The Fenwal Amicus system is used to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells.
The label change means platelets collected via the Fenwal Amicus system can now be stored for 7 days instead of 5, but conditions apply.
“Our customers now have the ability to store and use 7-day platelets processed by Amicus to help meet an important need in transfusion medicine,” said Dean Gregory, of Fresenius Kabi North America, the company that manufactures the Fenwal Amicus system.
“We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”
Previously, platelets were limited to a shelf life of 5 days due to the absence of appropriate bacterial testing methods and appropriate instructions for use.
The label change for the Fenwal Amicus system means blood centers that want to store apheresis-derived platelets for 7 days must label every product with a statement that the product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”
To support this requirement, Fresenius Kabi distributes the Verax Platelet PGD test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for use in leukoreduced apheresis platelets 24 hours prior to transfusion.
For more information on the Verax Platelet PGD test, visit the Verax Biomedical website. For more information on the Fenwal Amicus system, visit the Fenwal website. 
The US Food and Drug Administration (FDA) has cleared a label change for the Fenwal Amicus system, a cell-separation device, to allow for 7-day storage of platelets collected via this system.
The Fenwal Amicus system is used to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells.
The label change means platelets collected via the Fenwal Amicus system can now be stored for 7 days instead of 5, but conditions apply.
“Our customers now have the ability to store and use 7-day platelets processed by Amicus to help meet an important need in transfusion medicine,” said Dean Gregory, of Fresenius Kabi North America, the company that manufactures the Fenwal Amicus system.
“We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”
Previously, platelets were limited to a shelf life of 5 days due to the absence of appropriate bacterial testing methods and appropriate instructions for use.
The label change for the Fenwal Amicus system means blood centers that want to store apheresis-derived platelets for 7 days must label every product with a statement that the product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”
To support this requirement, Fresenius Kabi distributes the Verax Platelet PGD test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for use in leukoreduced apheresis platelets 24 hours prior to transfusion.
For more information on the Verax Platelet PGD test, visit the Verax Biomedical website. For more information on the Fenwal Amicus system, visit the Fenwal website.
The US Food and Drug Administration (FDA) has cleared a label change for the Fenwal Amicus system, a cell-separation device, to allow for 7-day storage of platelets collected via this system.
The Fenwal Amicus system is used to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells.
The label change means platelets collected via the Fenwal Amicus system can now be stored for 7 days instead of 5, but conditions apply.
“Our customers now have the ability to store and use 7-day platelets processed by Amicus to help meet an important need in transfusion medicine,” said Dean Gregory, of Fresenius Kabi North America, the company that manufactures the Fenwal Amicus system.
“We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”
Previously, platelets were limited to a shelf life of 5 days due to the absence of appropriate bacterial testing methods and appropriate instructions for use.
The label change for the Fenwal Amicus system means blood centers that want to store apheresis-derived platelets for 7 days must label every product with a statement that the product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”
To support this requirement, Fresenius Kabi distributes the Verax Platelet PGD test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for use in leukoreduced apheresis platelets 24 hours prior to transfusion.
For more information on the Verax Platelet PGD test, visit the Verax Biomedical website. For more information on the Fenwal Amicus system, visit the Fenwal website.