March 7, 2001
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...
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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...
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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....
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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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