Company:Roche Molecular Systems, IncDate of Enforcement Report:8/8/2007 Class:ll PRODUCT a) Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests, Recall # Z-1106-2007; b) Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0, Catalog number 03576710190, Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122,...Read More

Company:Medtronic Emergency Response Systems, IncDate of Enforcement Report:8/8/2007 Class:ll PRODUCT Biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers), Recall # Z-1148-2007 REASON Reduced Shock. The device may deliver 100 Joule (J) to a patient, which is less than...Read More