Lower risk Medical device recall · FDA · Published August 4, 2020

Hologic Panther Fusion Tube Tray Recall: Leaks May Cause False Negative Results

Hologic recalls Panther Fusion Tube Tray (FAB-15004) due to potential leaks causing false negative results in flu, RSV, and paraflu assays. Affected units include specific box/tray lots listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2990-2020Medical device Hologic ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmHologic, Inc10210 Genetic Center Dr · San Diego, CA 92121-4362

✎ GovInfoNow plain-language explainer

Hologic is recalling Panther Fusion Tube Trays with part number FAB-15004 because they may leak, leading to false negative results in flu, RSV, and paraflu tests. This could delay patient results and cause inaccurate test outcomes. Read more at govinfonow.com/recall/64535-hologic-panther-fusion-tube-tray-recall-leaks-may-cause-false.

Source Summary by GovInfoNow · govinfonow.com/recall/64535-hologic-panther-fusion-tube-tray-recall-leaks-may-cause-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2990-2020

Cite this page

“Hologic Panther Fusion Tube Tray Recall: Leaks May Cause False Negative Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64535-hologic-panther-fusion-tube-tray-recall-leaks-may-cause-false. Based on FDA recall #Z-2990-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2990-2020%22&limit=1).

The FDA announced on August 4, 2020, that Hologic, Inc. is recalling Panther Fusion Tube Trays due to potential leakage that could invalidate patient results or cause false negatives. The agency issued recall number Z-2990-2020 for the voluntary Class II action.

How to tell if you have it

Brand: Hologic
Product: Panther Fusion Tube Tray
Part: FAB-15004
REF: PRD-04000
Box/Tray lots: 271436/618539, 271438/620899, 272089/620899, 272959/621837, 272970/621256, 272971/621837, 274670/625351
Units affected: 607

The hazard

The 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.

Context

GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since June 27, 2017. Other recent recalls include the Hologic 3D Mammography Systems Recall (April 8, 2026) and the Hologic Genius Review Station Display Recall (March 23, 2026). Other recent recalls of similar products include the ICU Medical Portex Spinal Tray Recall (December 19, 2025), the AVID Medical Halyard Head and Neck Tray Recall (November 14, 2025), and the Medline ENFIT G-TUBE Connector Recall (February 13, 2026).

How to tell if you have this one

Check the box/tray lot numbers listed: 271436/618539, 271438/620899, 272089/620899, 272959/621837, 272970/621256, 272971/621837, 274670/625351. The product is sold under the Hologic brand.

Brand
Hologic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Look for the box/tray lot numbers listed in the recall notice: 271436/618539, 271438/620899, 272089/620899, 272959/621837, 272970/621256, 272971/621837, 274670/625351.

Where it went and when

Where it was distributed

Distributed in 24 states and D.C..

FDA distribution: “U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Maine, Massachusetts, New Jersey, New York, North Carolina, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 4.4 years after the firm started it.

Aug 4, 2020Firm started the recall
Sep 21, 2020FDA classified it Class II
Sep 30, 2020Published in FDA’s Enforcement Report
Dec 23, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64535-hologic-panther-fusion-tube-tray-recall-leaks-may-cause-false">Hologic Panther Fusion Tube Tray Recall: Leaks May Cause False Negative Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2990-2020 (August 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2990-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.