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Life Technologies Corporation recalls Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vi
Recalled May 2, 2018 · FDA recall Z-1480-2018 · Life Technologies
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. · FDA Class II
Units
30
Sold at
Distributed to states: AZ, CA, NC, TX, and VA.
Description
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.
Product
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Manufacturer(s)
Life Technologies Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →