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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.

 

Nationwide Voluntary Recall Issued for Tecan Clinical Workstation

 

Contact:
Lori LeRoy
(317) 521-7159

 

FOR IMMEDIATE RELEASE -- May 7, 2004 -- Roche Diagnostics today announced two voluntarily initiated recalls to make field corrective actions for the Tecan Clinical Workstation (TCW) that is used with Roche Diagnostics Amplicor® CT/NG test for the detection of Chlamydia and gonorrhea.

The first field corrective action references that Roche Diagnostics received reports from two laboratories in the U.S. regarding a malfunction discovered in the course of routine testing using the TCW. An investigation by Roche Diagnostics and Tecan, the manufacturer of the TCW and its software, determined that a software error could cause a mismatch among patient samples and test results. To Roche Diagnostics' knowledge, all reported cases the error was noticed before results were reported out and no patient results were adversely affected.

Roche Diagnostics initiated a field corrective action that included notifying customers and asking them to perform a manual workaround until the software can be corrected. Roche Diagnostics is working directly with the U.S. Food and Drug Administration to ensure that all appropriate parties are notified.

On a separate matter, Roche Diagnostics also issued a field corrective action of the Tecan Clinical Workstation that is used with the Amplicor CT/NG test for the detection of Chlamydia and gonorrhea due to a purging issue with the Tecan software.

The manufacturer of the TCW, Tecan, notified Roche Diagnostics 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 may mismatch sample results and sample identification. Again, to Roche Diagnostics' knowledge, in all reported cases the error was noticed before results were reported out and no patient results were adversely affected.

Roche Diagnostics initiated a field corrective action that included notifying customers and asking them to perform a purge of their data on a monthly basis.

All Tecan Clinical Workstations with Robonet software and that are used with the Roche Diagnostics Amplicor CT/NG assay are affected. Laboratories with questions can contact Roche Diagnostics at 1-800-526-1247. Patients who are concerned about the results of a Chlamydia and gonorrhea test should consult their physician.

Laboratory customers who need to review the field correction action can do so by logging into their customer website at www.mylabonline.com.

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