The Food and Drug Administration issued a safety advisory on Haemonetics' Leukotrap RC System, warning that faulty filters in some of the recently distributed devices can result in high leukocyte counts in blood used for transfusions.
Leukocytes are typically removed from blood collected for transfusions to reduce the risk of adverse reactions caused by the patient's own immune cells attacking the foreign cells.
Covina, Calif.-based Haemonetics first alerted customers about the issue on June 8 when it issued a recall notice for three recent lots of the Leukotrap RC System.
Less than two weeks later, the company expanded the recall to include all lots of the device distributed between April 14 and June 27.
Haemonetics instructs customers to label any blood products collected using Leukotrap RC Systems as non-leukoreduced, unless the devices have been tested and confirmed to have proper filter function, according to a letter the company wrote to its customers on June 21.
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