Company: Data Innovations. Date of Enforcement Report: 9/11/2013 Class ll: PRODUCT 1. Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Recall Number B-2265-13 2. Data Innovations Instrument Manager software Model – Versions 8.12.01 Recall Number B-2299-13 REASON Laboratory software, with a defect...Read More

Company: Nidek Inc. Date of Enforcement Report: 9/11/2013 Class llI: PRODUCT WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes. Recall Number Z-2131-2013 REASON The recall of the WASP (Walk Away...Read More