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Roche recall

This article was originally published in The Gray Sheet

Executive Summary

Cobas Taqman and Taqman 48 analyzer Class I recall is ongoing, after the discovery that some analyzers have an "improperly seated fiber optic cable," which could falsely elevate patient hepatitis B and C virus test results. Because physicians stop or change treatment upon finding elevated test results - which show patients failing to respond to treatment - disease progression or death could result in some cases. Roche is considering redesigning the optic cable, and says its field service engineers have inspected 100 analyzers for correct cable seating. The Taqman action is a further example of an increased number of Class I recalls compared with prior years (1"The Gray Sheet" July 19, 2004, p. 16)...

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