Hologic recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits that may give false positive results for SARS-CoV-2. Affected kits have specific lot numbers and expiration dates.
“Hologic Panther Fusion SARS-CoV-2/Flu Assay Kit False Positive Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53518-hologic-panther-fusion-sars-cov-2-flu-assay-kit-false. Based on FDA recall #Z-0694-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0694-2025%22&limit=1).
Hologic, Inc. voluntarily recalled the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay because it may erroneously produce false positive results for SARS-CoV-2, according to the FDA on November 8, 2024.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Context
GovInfoNow's records show Hologic, Inc. has had 30 other recalls since June 27, 2017. Recent Hologic recalls include the April 8, 2026, 3D Mammography Systems Recall for loose bolts and the March 23, 2026, Genius Review Station Display Recall for user modification risks. Other recent recalls of similar products include the November 22, 2025, S. Typhi/Para Ty false test results risk and the December 15, 2025, Diagnostica Stago Asserachrom HPIA Kit recall for false negative results.
How to tell if you have this one
Check for the kit lot number 892307 or cartridge lot number 890494. The expiration date is May 15, 2025, and the product is labeled as Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the kit lot number 892307 on the product label.
Check Cartridge Lot Number
Check the cartridge lot number 890494 on the product label.
Where it went and when
Where it was distributed
Distributed in Alaska.
Listed by the agency
Not listed
FDA distribution: “US: AK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska.
Recall timeline
FDA published this recall 54 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-0694-2025 (November 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0694-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.