Company: Medtronic Surgical Navigation Technologies, Inc.Date of Enforcement Report: 4/20/05 Class: II PRODUCT Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. Recall # Z-0711-05. REASON The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make...Read More

Company: Maquet, IncDate of Enforcement Report: 4/20/05 Class: II PRODUCT KION Anesthesia System. Recall # Z-0710-05. REASON Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality. CODE Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394;...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05. REASON The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall # Z-0672-05. REASON An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05. REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05. REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604. Recall # Z-0676-05....Read More