Company: The Soule Co. Inc.Product:Rapid Foam and other styrofoam products Date: 9/15/04 Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results and all activities are documented as required by 21 CFR...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 9/15/04 Class: II PRODUCT MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-1371-04. REASON A hardware/software problem will result in low elution volumes and bias sample results for various protocols. CODE All units using software version 3.03. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp, Indianapolis, IN, by...Read More

Company: Roche Diagnostics Corp.Date of Enforcement Report: 9/15/04 Class: II PRODUCT a) Roche/Hitachi 747 – 100 clinical chemistry analyzer; catalog number 04009223680. Recall # Z-1428-04; b) Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001. Recall # Z-1429-04; c) Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160. Recall #...Read More

Company:Guardian Drug Co. Inc.Product:Infant Gas Relief Drops, Nausea Contorl Cherry Liquid, Gastro Bismuth Liquid and other drugs Date: 9/15/04 Regarding Observation 15, your response indicates that the computer software was initially validated in April 2001 and that it was going to be revalidated in May 2004. You also included the validation report of the software...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 9/15/04 Class: II PRODUCT COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also...Read More