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

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The reagent kits may not stay stable properly, causing tests to show negative results when the disease is actually present. This could lead to missed diagnoses and incorrect health decisions.

Who’s affected

Healthcare professionals using the Panther Fusion System for diagnostic testing. Those who use the reagent kits for medical testing are most at risk of incorrect results.

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.

✎ GovInfoNow

Questions people ask

Why is this reagent being recalled?

The reagent kits may not stay stable properly, causing false negative test results which could miss disease presence.

What should I do if I have the recalled reagent?

Check the lot numbers on the packaging. If they match 281375 or 291829, stop using the reagent and contact Hologic for guidance.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for the reagent kits.

Take action

Contact Hologic

We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0750-2022 — Hologic Hologic

Hello,

I own a Hologic that is covered by recall Z-0750-2022 from Hologic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Hologic, Inc recalls Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X

Lower-risk recall