Company:Alaris Products, FDA News FOR IMMEDIATE RELEASE P06-119 August 28, 2006 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA United States Marshals Seize Defective Infusion Pumps Made by Alaris Products Pumps Can Deliver Excess Medication and Harm Patients At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the...Read More

Company: BEckman Coulter Inc. Date of Enforcement Report:9/6/2006 Class:ll PRODUCT UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4, Recall # Z-1440-6 REASON Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly...Read More

Company:Bayer Healthcare, LLC Date of Enforcement Report:9/6/2006 Class:ll PRODUCT ADVIA 2120 systems –Automated Complete Blood Cell and Differential Cell Counter, Recall # Z-1376-06 REASON The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso...Read More