Exact FDA event identifier

Event 95731

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

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Event summary

Timeline bucket: November 08, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Hologic, 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

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Z-0694-2025

Recall number: Z-0694-2025
Initiated: November 08, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Hologic, Inc.
Quantity: 3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

Code information

UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494

Distribution pattern

US: AK