Beckman Coulter Lab Automation Device Cleared

FDA has cleared a Beckman Coulter 510(k) for the DxA 5000 total laboratory automation system. The device is intended to help eliminate preanalytical errors by automatically detecting patient tube parameters such as sample identification, tube type, orders pending and tube weight, the company says. It is designed to focus on sample quality assessment, screening each sample at multiple points to help reduce the risk of errors and alerts lab technicians if action is needed, it says. The device also reduces the number of manual steps in sample processing from 32 steps to four.

Beckman Coulter says that research shows errors that occur in the pre-analytical phase of testing may contribute up to 75% of erroneous test results, with 26% possibly having an adverse effect on patient care. Most of the factors causing erroneous results occur outside the laboratory, including inadequate volume, mislabeled samples and incorrect tube type, it says.