Company: Stentor, Inc.Date of Enforcement Report:1/25/2006 Class:lI PRODUCT “iSite” PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3, Recall # Z-0399-06 REASON When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the patient/exam selected and shown may be different on the radiologist console and...Read More

Company: Instrumentation Laboratory Co., Lexington, MA.Date of Enforcement Report:1/25/2006 Class:lI PRODUCT GEM PREMIER 3000, Point-of-care blood analyzer. Recall # Z-0378-06 REASON Software error may report higher results for glucose and lactate. CODE Serial numbers starting with 18412 RECALLING FIRM/MANUFACTURER nstrumentation Laboratory Co., Lexington, MA, by letter dated December 16, 2005. Firm initiated recall is ongoing...Read More

Company: Abbott Laboratories, Inc.Date of Enforcement Report:1/25/2006 Class:lI PRODUCT ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, Recall # Z-0398-06 REASON System software assigns a calibrator default volume of 2.OuL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0...Read More

Company: Beckman Coulter Inc.Date of Enforcement Report:1/25/2006 Class:II PRODUCT Cytomics FC500 Cytometer with CXP Software, Part Numbers 629636 629637, Recall # Z-0380-06 REASON Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0. CODE CXP Cytometer Software Version 2.0 (acquisition software...Read More