The test expands the firm's Zika product pipeline, which also consists of a molecular assay authorized for emergency use.
FDA's alert said that the CDC confirmed less than half of the results that were presumed positive by LabCorp using the ZIKV Detect test.
Hologic CEO Steve MacMillan said that the deal is so compelling that the firm needed to do it now.
The CDC noted that if the test yields a negative RNA NAT result, clinicians should then analyze patient serum using an IgM antibody test.
The kit is a qualitative nucleic acid assay designed to test for Zika, dengue, and chikungunya viruses simultaneously.
Professional, molecular, and tissue diagnostics sales continued to grow during the first three quarters, while diabetes care sales remained in decline.
The Chinese firm is also developing a menu of extraction-free molecular diagnostic tests using a proprietary "one-step" reagent.
The updates include the addition of urine as a specimen type and commercially-sourced inactivated virus as a positive control.
The firm's Sentosa SA ZIKV RT-PCR Test detects Zika virus RNA from 22 samples in three hours using an automated workflow.
The device, which will be tested in collaboration with a Panamanian research institute, will run 40-minute tests without the need for electricity.