Reported Jan 1, 2025 · Ongoing

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

Hologic, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hologic, Inc. · 10210 Genetic Center Dr · San Diego, CA · 92121-4362

Is this the product you have?

  • Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
  • REFPRD-07400
Lot codes and dates
  • UDI-DI15420045515352 Kit lot 892307
  • Expiration
    • May 15
    • 2025. Cartridge Lot 890494
Amount recalled
3

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.