FDA-Device2018-05-02Class II
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Life Technologies Corporation
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.
Sold states
Distributed to states: AZ, CA, NC, TX, and VA.
Affected count
30
Manufactured in
7335 Executive Way, N/A, Frederick, MD, United States
Products
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief