Recipient: Inoveon Corp.Product: Diabetic Retinopathy 3DT System Date: 4/27/05 Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses and include risk analysis, as required by 21 CFR 820.30(g) [FDA 483, Item 15]. For example, a formal risk analysis of the...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/27/05 Class: III PRODUCT Version 12 software program written for the Bio- Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05. REASON The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/27/05 Class: III PRODUCT Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. Recall # Z-0703-05. REASON When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model...Read More