FDA recall Z-1480-2018

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-02-08

Report date

2018-05-02

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Frederick, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2018