Company: Siemans- ACUSON Aspen Diagnostic Ultrasound System Date of Enforcement Report 3/12/2008 Class:ll PRODUCT Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008 REASON Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead...Read More

Company: Roche Diagnostics Corp Date of Enforcement Report 3/12/2008 Class:ll PRODUCT Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Recall # Z-0576-2008 REASON Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp.,...Read More

Company: BD Biosciences, Date of Enforcement Report 3/12/2008 Class:ll PRODUCT BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008 REASON Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without...Read More