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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Tecan US Issues Nationwide Voluntary Recall of Tecan Clinical Workstation

Carl Severinghaus
(919) 361 5200

FOR IMMEDIATE RELEASE -- Research Triangle Park, NC -- June 21, 2004 -Tecan US, Research Triangle Park, North Carolina today announced a voluntary recall to make field corrections for Tecan Clinical Workstations. The Tecan Clinical Workstations (TCW) have been found to mismatch patient identification and test results in some cases. The workstations are used to test for gonorrhea, Chlamydia and drug abuse.

The voluntary recall includes the Tecan Clinical Workstation and no other models or software of the Tecan products. Tecan US distributed the Tecan Clinical Workstation in the US through direct sales and distributors.

Tecan US received reports from three laboratories in the U.S. regarding a malfunction discovered in the course of routine testing using the TCW. An investigation by Tecan US , distributors and customers determined that a software error could cause a mismatch among patient samples and test results. To Tecan’s knowledge, all reported cases were noticed before results were reported out and no patient results were adversely affected.

Tecan US notified distributors and customers that if an operator of the TCW fails to purge the TCW’s data management system on a regular basis, in accordance with the TCW’s operating instructions, the TCW’s software might mismatch sample results and sample identification. Tecan and the distributors of TCW initiated a field corrective action that included asking customers to perform a purge of their data on a monthly basis. Again, to Tecan’s knowledge, in all reported cases the error was noticed before results were reported out and no patient results were adversely affected.

Further, Tecan US identified the root cause of known occurrences with mismatched merging of sample identification and sample result using the TCW software and issued a retrofit of software (version 5.1.1) for the TCW to assure that results are not affected.

Laboratory customers who need to review the field correction action may contact Tecan Technical Support at 1-800-352-5128. Patients who are concerned about the results of a test performed on the TCW should consult their physician. Tecan US will continue to work closely with the FDA, TCW distributors and TCW customers to alert facilities against mismatched sample identification.


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