Grifols Gains FDA Approval for Procleix WNV Assay Alongside Babesia and Ultrio Elite Updates

A June 10, 2026 FDA approval letter covering Grifols Diagnostic Solutions' Procleix WNV Assay, Procleix Babesia Assay, and Procleix Ultrio Elite Assay arrives as blood centers and biologics facilities enter peak West Nile Virus transmission season, tightening the compliance window for donor screening programs already operating under 21 CFR Part 211 and biologics licensing requirements.

The Procleix WNV Assay (STN: BL 125121) is a qualitative in vitro nucleic acid test run on the Procleix Panther System. It detects WNV RNA in plasma specimens from individual human donors of whole blood and blood components, living donors, and organ donors where specimens are collected while the donor's heart is still beating. The assay also supports pooled testing of human plasma comprised of equal aliquots from not more than 16 individual donations.

Cadaveric, or non-heart-beating, donor screening is explicitly within scope. Two specimen types are excluded: cord blood and any diagnostic application. Facilities using the assay for anything beyond its labeled donor-screening indication would be operating outside the approved use, a distinction that QA directors should confirm is reflected in current SOPs and training records.

The combined approval letter is the fifth regulatory action on the Procleix WNV Assay since May 2018, with prior letters issued in January 2020, November 2020, and October 2024. The bundling of three assay approvals into a single June 2026 letter suggests coordinated labeling or manufacturing updates across the Procleix platform, details that biologics facility compliance teams should pull from the updated package insert before the next internal audit cycle.

For blood center QA leads, the practical read centers on pool-size limits and donor-type eligibility: the 16-donation pool ceiling and the cadaveric donor inclusion are parameters that feed directly into batch records and process validation documentation under an ICH Q10-aligned quality system. Any facility that expanded or modified pooling protocols since the October 2024 approval should verify alignment with the current labeling.

The updated package insert and the June 10, 2026 approval letter are posted to the FDA vaccines, blood, and biologics product page, and the Summary Basis for Regulatory Action from the original 2018 approval remains available for facilities conducting retrospective compliance reviews.

Blood centers and biologics facilities should confirm that current donor screening SOPs, equipment qualification records for the Panther System, and staff training documentation reflect the approved indications before the next FDA inspection cycle.

Source: FDA Vaccines, Blood and Biologics product page via What's New Vaccines Blood Biologics RSS Feed, June 15, 2026.