Lower riskMedical device recall · FDA · Published October 10, 2019
Hologic Panther Fusion Reagent Recall: False Test Results Risk
Hologic recalls Panther Fusion Extraction Reagent-S (lot 258402) due to potential false positive/negative flu test results. Affected users should contact for remedy.
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
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-S kits because a component may cause false positive or false negative flu test results. This could lead to incorrect diagnoses and delayed treatment. The recall affects specific lot numbers sold in the U.S. Read more at govinfonow.com/recall/66828-hologic-panther-fusion-reagent-recall-false-test-results-risk.
“Hologic Panther Fusion Reagent Recall: False Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66828-hologic-panther-fusion-reagent-recall-false-test-results-risk. Based on FDA recall #Z-2163-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2163-2020%22&limit=1).
The FDA announced on Oct. 10, 2019, that Hologic, Inc. is recalling Panther Fusion Extraction Reagent-S due to a hazard that may cause false positive or negative flu test results. Owners should contact the company for a remedy.
The reagent component included in the flu test kit may cause high background signal in true negative samples, leading to false positive and/or false negative results. This could result in invalid runs or incorrect results being reported, potentially causing a delay in treatment.
Context
GovInfoNow's records show Hologic, Inc. has had 30 other recalls on record since June 27, 2017. Recent Hologic recalls include the Feb. 18, 2026 Aptima HPV Assay Kit recall for false negative results risk and the March 23, 2026 Genius Review Station Display recall for user modifications risk safety. Other recent recalls of similar products include the July 24, 2026 Biomerieux VITEK 2 AST-N461 Test Kit recall for false resistant results risk and the Nov. 22, 2025 Changchun Wancheng Bio-Electron UTI Test Strips recall for false results risk inappropriate treatment.
How to tell if you have this one
Check for lot numbers 258402 (reagent), 257472 (capture reagent), and 257473 (enhancer reagent) on the packaging. The product is sold as a flu test kit with UDI 15420045509214.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Hologic
Reach out to Hologic for instructions on returning or replacing the reagent kits.
Where it went and when
Where it was distributed
Distributed in 14 states.
Listed by the agency
Not listed
FDA distribution: “US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Florida, Idaho, Illinois, Indiana, Louisiana, New Mexico, New York, Pennsylvania, Texas, Utah, Washington, Wisconsin.
Recall timeline
FDA published this recall 8 months 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-2163-2020 (October 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2163-2020 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.