Company: Beckman Coulter, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03. CODE Software version 3.29. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing. REASON Defective software media distributed with...Read More

Company: ABX Diagnostics, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03. REASON Instrument fails to obtain correct patient information/results due to malfunction of the equipment’s sample door. CODE Software versions of up to 1.7. RECALLING FIRM/MANUFACTURER ABX Diagnostics, Inc., Irvine, CA, by letter on June 5,...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 9/10/03 Class: II PRODUCT Abbott Aeroset System list number 9D05-01. Recall # Z-1142-03. REASON ICT assays run using a manual dilution will not be calculated correctly by the software. CODE All units. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter dated December 29, 2000. Firm initiated recall...Read More