Lower risk Medical device recall · FDA · Published January 27, 2022

Hologic Panther Fusion Reagent-X Recall: False Negative Test Risk

Hologic recalls Panther Fusion Extraction Reagent-X (lot 281375, 291829) due to potential false negative test results. Affected kits may not detect diseases correctly.

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

🇺🇸 FDA recall #Z-0750-2022Medical device Hologic ›

Lower-risk recall

Failed stability specifications for reagent kits that may result in false negative test results.

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 Extraction Reagent-X reagent kits because they may cause false negative test results. This means tests could miss disease presence, leading to incorrect health conclusions. Read more at govinfonow.com/recall/61218-hologic-panther-fusion-reagent-x-recall-false-negative-test-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61218-hologic-panther-fusion-reagent-x-recall-false-negative-test-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0750-2022

Cite this page

“Hologic Panther Fusion Reagent-X Recall: False Negative Test Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61218-hologic-panther-fusion-reagent-x-recall-false-negative-test-risk. Based on FDA recall #Z-0750-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0750-2022%22&limit=1).

The FDA announced on Jan. 27, 2022, that Hologic, Inc. is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Hologic
Product: Panther Fusion Extraction Reagent-X, REF PRD-04477
Lot Numbers: 281375, 291829, 281330, 290312, 281332, 290331

The hazard

The reagent kits failed stability specifications, which may result in false negative test results. The recall involves 264 kits distributed worldwide and in the United States.

Context

GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since June 27, 2017. Other recent recalls of similar products include Hologic SELENIA Dimensions Mammography Systems Recall (April 8, 2026), Hologic Genius Review Station Display Recall (March 23, 2026), and Hologic Aptima HPV Assay Kit Recall (Feb. 18, 2026). Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025).

How to tell if you have this one

Check for lot numbers 281375 or 291829 on the Panther Fusion Extraction Reagent-X packaging. The kit includes Panther Fusion Capture Reagent-X (FCR-X) and Panther Fusion Enhancer Reagent-X (FER-X).

Brand
Hologic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Lot Numbers
Look for lot numbers 281375 or 291829 on the Panther Fusion Extraction Reagent-X packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 25 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 55 days after the firm started it.

Jan 27, 2022Firm started the recall
Mar 11, 2022FDA classified it Class II
Mar 23, 2022Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61218-hologic-panther-fusion-reagent-x-recall-false-negative-test-risk">Hologic Panther Fusion Reagent-X Recall: False Negative Test Risk (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-0750-2022 (January 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0750-2022 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.