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Medical Devices

Press Release from TOSOH Bioscience, Inc.

The following document is a copy of a Press Release from TOSOH Bioscience, Inc. See the nearby link to the recall notice related to this 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.

PRESS RELEASE: November 24, 2004

Judy Huff, Associate Director of Marketing, 1-800-248-6764

TOSOH Bioscience, Inc. Issues Nationwide Recall of AIA-600 II Software Version

TOSOH Bioscience, Inc. South San Francisco, CA has initiated a voluntary product recall of the AIA-600 II Software Version 3.02 and lower for customers who perform the ST AIA-PACK cTnI 2nd-Gen assay. The recall was initiated April 1, 2003. Software versions, 3.12 and higher improve the washing procedure for the assay and have been installed on the AIA-600 II. Software versions 3.12 and higher have resolved the problem.

TOSOH Bioscience, Inc. has received many complaints from customers regarding the inaccuracy of the cTnI 2nd-Gen assay on the AIA-600 II with Software Versions 3.02 and lower. An investigation determined that some instruments using the older software versions might demonstrate a lack of washing effectiveness at the B/F separation step, which could potentially result in false positive test results of the assay. False negative results have also been observed which may be software related and are under investigation. In a clinical setting, inappropriate treatment could be administered to a patient based on these incorrect results which could result in potentially serious or life threatening injuries. Laboratories have been advised to alert their physician users to use these test results with particular care.

TOSOH Bioscience, Inc. initiated a corrective action by upgrading all customers who currently perform the cTnI 2nd-Gen assay on the AIA-600 II to software version 3.12 or higher. To date, eighty-three instruments in the U.S. have been upgraded. Three overseas customers have also been upgraded. One instrument remains to be upgraded. The FDA has been apprised of this action.

All AIA-600 II instruments are currently being shipped with software version 3.14. Customers who do not perform the cTnI 2nd-Gen assay will be upgraded at the next service call or preventive maintenance call.

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