FDA recall Z-0042-2025

Product

NxTAG Respiratory Pathogen Panel, REF: I051C0447

Reason for recall

Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

Distribution

U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.

Key facts

Status

Ongoing

Initiation date

2024-09-05

Report date

2024-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0042-2025