Company: Tri-State Analytical Laboratory LLCProduct: Analyzed drug products Date: 10/22/03 Inadequate Standard Operating Procedures that are not always available, lack appropriate details, or contain contradictory information. For example, the written procedure for method validation lacks detailed instructions and acceptance criteria for each test and conflicts with the protocol. Additionally, some software application and microbiology lab...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 10/22/03 Class: II PRODUCT Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04. REASON Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted. CODE All units with current software...Read More

Company: Olympus America Inc.Date of Enforcement Report: 10/22/03 Class: II PRODUCT Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04. REASON Software malfunction; potential for simultaneous cross-linking of...Read More