Company: Tri State IncorporatedDate of Enforcement Report:2/12006 Class:lI PRODUCT Oxygen Compressed USP, size M6, D, E, C, M, and MN cylinders, Recall # D-144-6 REASON cGMP deviations: FDA inspection of the recalling firm found that the Auto HP computerized filling system is not validated and there is no way to verify the automated vent and...Read More

Company: Roche Diagnostics Corp.Date of Enforcement Report:2/1/06 Class:II PRODUCT a) Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.), Recall # Z-0417-06; b) Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed within the U.S.), Recall # Z-0418-06; c) Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed...Read More

Company: Datascope Corp.Date of Enforcement Report 2/1/2006 Class:lI PRODUCT Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor, Recall # Z-0437-06 REASON Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off. CODE All Panorama Central Station containing software versions 8.1.6 through 8.2 RECALLING...Read More