Company:Terumo Cardiovascular Systems Corp Date of Enforcement Report:1/5/2007 Class:ll PRODUCT a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007; b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within...Read More

Company:Beckman Coulter Inc., Date of Enforcement Report:1/4/2007 Class:ll PRODUCT LFC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007 REASON The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog...Read More