Company: Hemosense Inc.Date of Enforcement Report:11/16/2005 Class:II PRODUCT Hemosense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21, Recall # Z-0132-06 REASON A software problem that may cause the INRatio meter to incorrectly display ‘INR>7.5′ test message under a particular use condition. 7.5’ test message under a particular use condition.” name=prdReason0 CODE Serial Numbers: 044609678,...Read More

Company: Diasorin Inc.Date of Enforcement Report: 11/16/2005 Class:II PRODUCT ETI-LAB Applications Disk (for programming Bio-Rad HIV-1/HIV-2 Plus O EIA Assay), Recall # B-0140-6 REASON Defect in the design of HIV-1/2 testing software resulting in an incorrect incubation temperature. CODE Version 1.0 RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN, by telephone and letter dated May 13, 2004....Read More