Nationwide Voluntary Recall Issued for Tecan Clinical Workstation
Contact: Lori LeRoy
Roche Diagnostics
(317) 521-7159
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.
AMPLICOR is a trademark of a Member of The Roche Group.
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