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FDAFebruary 8, 2018device

Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.

What to do

FDA enforcement status: Terminated

Brands named

life technologieslife

UPCs

10190302006385

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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