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About Particulate Matter in Blood Bags

Recently, the American Red Cross (ARC) has reported finding multiple units of blood and blood components that contain white particulate matter in a small percentage of blood bags manufactured by a leading multinational Blood Bag Manufacturer. The preliminary reports to FDA indicate that some particles are consistent with platelet clumps.

FDA has also received a small number of adverse event reports in patients who received transfusions utilizing such bags, including one fatality that occurred in a severely ill patient. Adverse events in the transfusion setting can occur for many reasons, including reasons related to and unrelated to the transfusion.

The procedures for examining liquid blood components for particulate matter are performed prior to leukoreduction and at the time of packing for distribution. They include placing the bag, label down, on a flat counter undisturbed for 10 minutes and then performing a visual examination for particles.

FDA has reminded blood establishments (both blood bag manufacturing and blood banking) of the need to have and follow appropriate visual inspection procedures for all blood and blood components.


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