Company: Roche Molecular Systems, Inc.Date of Enforcement Report: 6/11/03 Class: II PRODUCT COBAS TaqMan analyzer, Series 96; catalog number 8080216. Recall # Z-0917-03. REASON A false positive result may be reported. CODE All units with software versions TaqLink v 1.0 or TaqLink v 1.1. RECALLING FIRM/MANUFACTURER Roche Molecular Systems, Inc., Belleville, NJ, by telephone, and...Read More

Company: MagneVu Product: Portable magnetic resonance imaging (MRI) system Date: 07/11/03 Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated....Read More

Company:Guidant Corp-Cpi Division.Date of Enforcement Report: 6/11/03 Class: II PRODUCT a) Pulsar Multiprogrammable Pacemaker, DDD Model 970. Recall # Z-0875-03; b) Pulsar Multiprogrammable Pacemaker, DDD Model 972. Recall # Z-0876-03; c) Pulsar Multiprogrammable Pacemaker, DDD Model 976. Recall # Z-0877-03; d) Pulsar Multiprogrammable Pacemaker, DDDR Model 1270. Recall # Z-0878-03; e) Pulsar Multiprogrammable Pacemaker, DDDDR...Read More