Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1480-2018

February 08, 2018

Class II

Product summary

Firm
Life Technologies Corporation
Event
Event 79649
Status
Terminated
Classification
Class II
Quantity
30
Official record key
device-enforcement:Z-1480-2018

Official wording

Reason: 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.

Code information: Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.