Company: Roch DiagnosticsProduct: Accu Check Inform Blood Glucose System Class II Date of Enforcement Report: 8/28/2002 All units that have ever displayed a temperature icon in conjunction with patient use. Reason: May give erroneous results if the temperature icon has ever been displayed with use. Manufacturer: Roch Diagnostics, Mannheim, Germany. Recalled by: Roche Diagnostics Corporation,...Read More

Company: Diasorin IncDate of Enforcement Report: 8/28/02 Class: II PRODUCT Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma. Recall # Z-1265-2. REASON As a result of a software error,...Read More