Reports to Greiner indicate several lots of the sample transfer units (stu) may leak due to the protective rubber sleeve bunching up and not retracting when using the device. The non reset of the rubber sleeve can depend on the device age and can be up to 23%. The sample transfer unit (stu) is a custom-made, single-use tube holder, used solely in plasma centers, to transfer a small amount of plasma from the bottle to the tube. Once transferred in the tube, plasma samples are tested to assure quality standards/specifications of the bottled plasma are met prior to sale. no patient treatment is performed at plasma centers. Since there is no venous pressure and personal protective equipment (PPE) is required when handling plasma samples, the risk to the user is minimal. Any possible leakage does not impact the device's capability to collect plasma sample nor the quality of the plasma sample. As a result, the potential effects of the detected error are viewed as low risk. Nevertheless, the leakage could still pose a minimal risk to the user, specifically if appropriate PPE is not worn. Therefore, the concerned lots of the device should not be utilized. Recall start date: November 4, 2024
RecallTracker