Hologic recalls 18-count Panther Fusion Tube Trays (PN: FA-15004) that may leak, causing false positive/negative test results. Affected units sold with specific lot numbers.
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Take action
Contact the company
📍Recalling firmHologic, Inc10210 Genetic Center Dr · San Diego, CA 92121-4362
“Hologic Panther Fusion Tube Tray Recall: Leaking Trays Risk False Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63213-hologic-panther-fusion-tube-tray-recall-leaking-trays-risk-false. Based on FDA recall #Z-1369-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2021%22&limit=1).
The FDA announced on Feb. 26, 2021, that Hologic, Inc. is recalling Panther Fusion Tube Trays due to a potential for leakage. This defect could result in false positive, false negative, or invalid patient results.
According to the FDA, there is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Context
GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since 2017-06-27. Other recent recalls of similar products include AVID Medical Halyard Head and Neck Tray Recall (2025-11-14) and Rocket 16Fg Seldinger Catheter Tray (2025-11-07).
How to tell if you have this one
Check for the product code FA-15004 (PN) with lot numbers listed in the description. The trays are sold as ancillary consumables for the Panther Fusion System.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Leaks
Inspect the tube trays for signs of leakage before use.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 31 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1369-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1369-2021 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.