Life Technologies Corporation recalls Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitr…

Recall date

February 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1480-2018

FDA classification

Class II

Brand / firm

Life Technologies Corporation

Sold / distributed

Distributed to states: AZ, CA, NC, TX, and VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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