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The QMN Weekly Bulletin

FDA Issues Critical Recall of Leukotrap RC System Blood Filters

Aug. 12, 2016

FDA is warning healthcare providers of faulty filters used in Haemonetics’ Leukotrap RC System that are associated with higher than expected levels of leukocytes in transfused blood.

The company initially alerted healthcare providers in a recall notice dated June 8, warning of three recent lots of the Leukotrap RC System filtered with its RC2D filter could yield blood products with a high leukocyte count.

The global manufacturer received further reports of higher than expected residual white blood cell counts associated with lot numbers beyond those described in the recall.

Within two weeks, the company expanded the recall to include additional lots following similar adverse reports, and it issued a voluntary recall of all lots distributed between April and June.

 Haemonetics advised healthcare providers to label any blood products collected using affected Leukotrap RC systems as non-leukoreduced, unless the products have been tested and confirmed to be adequately filtering leukocytes.

 In its safety advisory, FDA’s Center for Biologics Research and Evaluation said such testing should be conducted within 48 hours of filtration, and any alternative procedures for counting leukocytes should be discussed with the agency beforehand.

Both FDA and Haemonetics caution blood collection establishments against re-filtering of affected blood products due to potential for damaging blood cells.

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