Company: Sunquest Information Systems, Inc.Date of Enforcement Report: 3/7/01 Date of Recall: 1/15/01 Class: II PRODUCT: Flexilab Laboratory Information System (not for use in blood banks). Recall #Z-0369-1. REASON: Software anomaly allows misprint of patient information. CODE: Flexilab version 5.23 with RBR module. MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ. RECALLED BY: Manufacturer, by fax...Read More

Company: Ortho-Clinical Diagnostics, Inc.Date of Enforcement Report: 3/7/01 Date of recall: 6/28/00 Class: III PRODUCT: Vitros 250 Chemistry Systems with Software Versions 6.x (6.0,6.01, 6.02, etc). Recall #Z-249-1. REASON: Test results may be mis-reported as 0.0 for any analyte including CK-MB, acetaminophen, iron, lithium, and salicylate. CODES: Catalog #8132086. Vitros 250 Chemistry System serial numbers...Read More

Company: Olympus America, Inc.Date of Enforecement Report: 3/7/01 Date of Recall: 10/1/99 Class: III PRODUCT: Integrated Endosurgery EndoALPHA Software Version 3.01. Recall #Z-381-1. REASON: The device software version 3.01 prevented the control unit from retaining the user-programmer coagulation setting. CODE: Catalog #UCES (Control Unit for Endosurgery), software version 3.01. MANUFACTURER: Olympus America, Inc., Melville, NY....Read More