Exact FDA event identifier

Event 96381

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 20, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Microbiologics Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

Z-1454-2025

Recall number: Z-1454-2025
Initiated: February 20, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Microbiologics Inc
Quantity: 28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The RSV target may give a late Ct value and could potentially not pass QC.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The RSV target may give a late Ct value and could potentially not pass QC.

Code information

UDI-DI: 10845357042184; Lot Number: HE0044-131

Distribution pattern

Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.