Lots of blood collection system recalled

Photo by Marja Helander

The US Food and Drug Administration (FDA) has announced a recall of 10 lots of the Leukotrap RC System with RC2D Filter, a blood collection system for leukoreduced red blood cells.

Haemonetics Corporation issued the recall due to reports of higher than expected residual white blood cells in blood processed with certain lot numbers of Leukotrap RC Systems with RC2D Filter.

The FDA said the problem is the result of a manufacturing assembly issue, and use of the affected lots may result in a higher than expected level of leukocytes in transfused blood.

Therefore, these lots should not be used, unused product can be returned to Haemonetics, and the company will replace these recalled lots. Customers can contact their local customer service representative to coordinate returns and shipments of replacement product.

The FDA said blood processed using the affected lots should not be re-filtered. If blood products processed by the affected lots are shown to have levels of leukocytes above recognized standards, the products should be labeled as non-leukoreduced. However, if the blood products have levels of leukocytes within recognized standards, they can still be labeled as leukoreduced.

The affected lots, which were shipped between April 2018 and July 2018, are:

• 1856199, Product ID 129-62
• 1856113, Product ID 129-63
• 1856114, Product ID 129-63
• 1856131, Product ID 129-63
• 1856134, Product ID 129-63
• 1856135, Product ID 129-63
• 1856183, Product ID 129-63
• 1856185, Product ID 129-63
• 1856186, Product ID 129-63
• 1856201, Product ID 129-63.

Photo by Marja Helander

The US Food and Drug Administration (FDA) has announced a recall of 10 lots of the Leukotrap RC System with RC2D Filter, a blood collection system for leukoreduced red blood cells.

Haemonetics Corporation issued the recall due to reports of higher than expected residual white blood cells in blood processed with certain lot numbers of Leukotrap RC Systems with RC2D Filter.

The FDA said the problem is the result of a manufacturing assembly issue, and use of the affected lots may result in a higher than expected level of leukocytes in transfused blood.

Therefore, these lots should not be used, unused product can be returned to Haemonetics, and the company will replace these recalled lots. Customers can contact their local customer service representative to coordinate returns and shipments of replacement product.

The FDA said blood processed using the affected lots should not be re-filtered. If blood products processed by the affected lots are shown to have levels of leukocytes above recognized standards, the products should be labeled as non-leukoreduced. However, if the blood products have levels of leukocytes within recognized standards, they can still be labeled as leukoreduced.

The affected lots, which were shipped between April 2018 and July 2018, are:

• 1856199, Product ID 129-62
• 1856113, Product ID 129-63
• 1856114, Product ID 129-63
• 1856131, Product ID 129-63
• 1856134, Product ID 129-63
• 1856135, Product ID 129-63
• 1856183, Product ID 129-63
• 1856185, Product ID 129-63
• 1856186, Product ID 129-63
• 1856201, Product ID 129-63.

Photo by Marja Helander

The US Food and Drug Administration (FDA) has announced a recall of 10 lots of the Leukotrap RC System with RC2D Filter, a blood collection system for leukoreduced red blood cells.

Haemonetics Corporation issued the recall due to reports of higher than expected residual white blood cells in blood processed with certain lot numbers of Leukotrap RC Systems with RC2D Filter.

The FDA said the problem is the result of a manufacturing assembly issue, and use of the affected lots may result in a higher than expected level of leukocytes in transfused blood.

Therefore, these lots should not be used, unused product can be returned to Haemonetics, and the company will replace these recalled lots. Customers can contact their local customer service representative to coordinate returns and shipments of replacement product.

The FDA said blood processed using the affected lots should not be re-filtered. If blood products processed by the affected lots are shown to have levels of leukocytes above recognized standards, the products should be labeled as non-leukoreduced. However, if the blood products have levels of leukocytes within recognized standards, they can still be labeled as leukoreduced.

The affected lots, which were shipped between April 2018 and July 2018, are:

• 1856199, Product ID 129-62
• 1856113, Product ID 129-63
• 1856114, Product ID 129-63
• 1856131, Product ID 129-63
• 1856134, Product ID 129-63
• 1856135, Product ID 129-63
• 1856183, Product ID 129-63
• 1856185, Product ID 129-63
• 1856186, Product ID 129-63
• 1856201, Product ID 129-63.