Reported Sep 30, 2020 · Terminated

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

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 Tube Tray
  • PartFAB-15004
  • REFPRD-04000
Lot codes and dates
  • Box/ Tray lots
    • 271436/ 618539
    • 271438/ 620899
    • 272089/ 620899
    • 272959/ 621837
    • 272970/ 621256
    • 272971/ 621837
    • 274670/ 625351
Amount recalled
607

Where it was sold

Why it was recalled

Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Hologic, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 23, 2024 · Data as of Sep 19, 6:50 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.