medical Class II Updated 2018-05-02

Life Technologies Corporation recalls Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Tar

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, NC, TX, VA
Lot/Code Info: Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
View official government recall

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