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LifeScan glucose meter recall

This article was originally published in The Gray Sheet

Executive Summary

Users of Johnson & Johnson's OneTouch Ultra, OneTouch FastTake and InDuo need not return the blood glucose monitors despite a Class I recall affecting the devices, FDA clarifies in a FDL-1public message on its website June 13. The monitors permit users to "accidentally change the unit of measure" by dropping the instrument or subjecting it to similar trauma. When J&J/LifeScan became aware of the problem earlier this year, it suspended shipments and notified users. "FDA believes that most patients are capable of understanding and following" the firm's instructions, the agency states, noting that LifeScan now offers alternative devices to curb test misinterpretation. LifeScan reps met with CDRH Director Dan Schultz and Office of In Vitro Diagnostic Devices Evaluation & Safety officials June 3...

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