Company:Bio-Rad, Laboratories IncDate of Enforcement Report 5/11/2011 Class ll: PRODUCT VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 5/11/2011 Class ll: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: – Complete Blood...Read More

Company: Hospira Inc. Date of Enforcement Report 5/11/2011 Class l: PRODUCT LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete...Read More