DATE RECALL INITIATED:

March 29, 2018

PRODUCT / LOT NUMBER:

Alyx Component Collection System
Affected Products Codes: 4R5725 and 6R5725

MANUFACTURER:

Fresenius-Kabi
Lake Zurich, Illinois

REASON:

Fresenius Kabi USA has initiated a mandatory software update Field Action of the Alyx Component Collection System, because of an issue identified when the Alyx instrument is used for the RBC/Plasma procedure, Alyx kit codes 4R5700 and X4R5700. Pre-leukoreduced RBC volumes as low as 172 mL for a 200 mL target have been reported. In these circumstances, donor RBC loss is underreported by up to 28 mL. Alyx 2RBC procedures are not affected by this issue.

Investigation has found that the pneumatic pumps are within specifications, but operating at the lower end of acceptable efficiency. As a result, at the end of an RBC/Plasma collection procedure, transfer of RBCs from the centrifuge to the collection container is ended before completion.

Fresenius Kabi plans to update devices to the new software version 3.2B. Customers will be contacted by a Fresenius Kabi service representative to schedule a service appointment for updating the software.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.