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Regulatory Focus™ > News Articles > Faulty Filter Prompts Recall of Leukocyte Reduction Device

Faulty Filter Prompts Recall of Leukocyte Reduction Device

Posted 23 June 2016 | By Michael Mezher 

Faulty Filter Prompts Recall of Leukocyte Reduction Device

The US Food and Drug Administration (FDA) on Thursday warned healthcare providers that a faulty filter in recently distributed lots of Haemonetics' Leukotrap RC System can result in higher than acceptable leukocyte counts in blood used in transfusions.

Leukocytes, commonly referred to as white blood cells, are typically removed from blood collected for allogenic transfusions in order to reduce the likelihood of adverse reactions caused by the patient's own immune cells attacking the foreign leukocytes. This can be done through several methods, including freeze-thawing, centrifugation or filtration.

Leukotrap RC Recall

Haemonetics first alerted its customers of the issue with a recall notice on 8 June, saying three recent lots of the Leukotrap RC System with its RC2D filter could yield blood products with a high leukocyte count. According to the recall notice, Haemonetics received reports of the issue for two lots, 1656076 (129-62) and 1656083 (129-63), but said that a third lot, 1656084, could also be affected.

However, less than two weeks later, Haemonetics expanded the recall to include all lots of the device distributed between 14 April 2016 and 27 June 2016, noting that the company had received additional reports indicating the issue was present in other lots as well.

In a letter to its customers dated 21 June 2016, Haemonetics instructs them 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 (CBER) says that such testing should be conducted within 48 hours of filtration, and says any alternative procedures for counting leukocytes should be discussed with the agency beforehand.

Additionally, both FDA and Haemonetics warn blood collection establishments against re-filtering affected blood products due to the potential for damaging blood cells.

However, FDA says if healthcare providers are short on adequately tested units of blood, they should prioritize adequately tested units for the most at-risk patients.

"In situations where leukocyte reduced red blood cells are unavailable for all patients, it may be prudent to triage the use of suitably tested units to patients at the highest risk of adverse events from exposure to leukocytes," FDA says.

Safety Advisory

Haemonetics Recall Extension


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