Company: Sunquest Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B-0627-2. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version numbers 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ,...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0666-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0667-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0669-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: 111 PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0671-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0668-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0670-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Biochem Immunosystems (U.S.), IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System, Recall # Z-0463-02. REASON Samples were not picked up and added to the dilution tube. CODE Version 2.2a Catalog # PL01. RECALLING FIRM/MANUFACTURER Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA,...Read More