Company: Misys Healthcare SystemsDate of Enforcement Report: 8/10/05 Class: II PRODUCT Misys Laboratory, Version 6.1, Recall # B-1566-5 REASON Defects in the design of software could result in loss of patient information. CODE Version 6.1 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile and e-mail dated May 20, 2005. Firm initiated recall is ongoing....Read More

Recipient: Boston Scientific Corp.Product:Vaxcel Low Profile Infusion Ports, Taxus paclitaxel drug eluting stents and Symmetry balloon dilation catheters Date: 8/10/05 Failure to analyze processes, work operations and other sources of quality data to identify existing and potential causes of non-conforming product as required by 21 CFR 820.100(a)(1). For example, we observed the release and actual...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 8/10/05 Class: II PRODUCT StemCXP Software, version 1.0 for Cytomics FC 500, Recall # B-1738-5 REASON StemCXP Software, which had a glitch or defect, was distributed. CODE Version 1.0 RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated February 24, 2005. Manufacturer: Beckman Coulter, Inc.,...Read More