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Medical Devices

Roche Molecular Systems Issues Nationwide Recall Of COBAS TaqMan Analyzers And COBAS TaqMan 48 Analyzers

The following document is a copy of a Press Release from Roche Molecular Systems, Inc. related to the Class I Medical Device Recall of Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers.

See the nearby link to the recall.

Press Release

Paula Evangelista
Roche Molecular Systems, Inc.

For Immediate Release

Roche Molecular Systems Issues Nationwide Recall of Cobas TaqMan Analyzers and Cobas TaqMan 48 Analyzers

PLEASANTON, CA. July 22, 2004-- Roche Molecular Systems, Inc. (RMS), Pleasanton, California, has initiated a nationwide recall of COBAS TaqMan Analyzers and COBAS TaqMan 48 Analyzers that are used by laboratories to run tests for hepatitis B and hepatitis C viruses and for other in-house diagnostic testing. A few Analyzers have been found to have an improperly seated fiber optic cable, which potentially could result in falsely elevated patient test results. Falsely elevated results would suggest that the patient is not responding to treatment and the physician may stop or change therapy. In some cases this could result in progression of the disease and, due to the disease progression, ultimately lead to death. In extreme cases, the misalignment of the fiber optic cable could result in a mismatch of patient test results. RMS will continue to monitor instruments in the field to assess that fiber optic cables are correctly seated.

Roche began this investigation upon the receipt of one customer complaint. Based on this complaint, no patient was inappropriately treated as a result of this situation.

Customers who have COBAS TaqMan Analyzers or COBAS TaqMan 48 Analyzers have been notified by Roche Diagnostics and have had their instruments inspected by a Roche Field Service Engineer to assure proper alignment of the fiber optic cable.

The firm voluntarily initiated this field correction after learning that false positive results generated in a laboratory were caused by a misalignment of the fiber optic cable to one of the thermal cycler blocks contained in the instrument. FDA has been apprised of this action.

Based on customer feedback and ongoing investigation, Roche Molecular Systems, Inc. has confirmed the possibility of falsely elevated control and patient values on the COBAS TaqMan and COBAS TaqMan 48 Analyzers. It has been determined that if a fiber optic cable is incorrectly seated in the emission module of a thermal cycler, the emission signals may overlap those of neighboring wells resulting in cross-talk that could lead to falsely elevated results. Extreme misalignment could result in a sample-to-result mismatch. Analyzers have been distributed to laboratories in the United States, Canada, and Europe. They can be identified by brand name COBAS TaqMan and COBAS TaqMan 48 Analyzer.

Roche Molecular Systems notified its distributors and customers by letter in May of this year. Field Service Engineers have inspected all Analyzers for correct seating of the cable.

Laboratories with questions may contact the company at 1-800-526-1247.


Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA, US
Communications & PR

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