Company: Philips Healthcare Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1609-2011 REASON Software: EtCO2 and Ventilation Rate...Read More

Company: Bio-Rad Laboratories, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data...Read More

Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT 2. Factor II (prothrombin) G20210A kit, catalog number 03610195001. The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, from DNA isolated from human whole...Read More

Company: Hemo Cue, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT 1) HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level. Recall # Z-1848-2011; 2) HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. Recall # Z-1849-2011 REASON Incorrect configurations settings in...Read More

Company: QIAGENDate of Enforcement Report 4/6/2011 Class ll: PRODUCT Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Recall # Z-1853-2011 REASON Image captured from the device may...Read More