Company: Roche Diagnostics, CorpDate of Enforcement Report: 8/6/03 Class: II PRODUCT MagNA Pure LC Instrument, Catalog number 2236931. Recall # Z-1044-03. REASON A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols. CODE All systems using software version 3.0. RECALLING FIRM/MANUFACTURER Roche...Read More

Company: Medex, IncDate of Enforcement Report: 8/6/03 Class: II PRODUCT Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea, (the pumps with different languages have different...Read More

Company: Abbott Laboratories HPD/ADDDate of Enforcement Report: 8/6/03 Class: II PRODUCT AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21 (French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0). Recall # Z-1047-03. REASON AFP results obtained when using the 1:101 automated dilution protocol showed an...Read More