Hologic Aptima HPV Assay Kit Recall: False Negative Results Risk
Hologic recalls Aptima HPV Assay Kit (model 303585) due to potential for false negatives. Affected kits may give incorrect results, leading to missed diagnoses. Contact Hologic for details.
Lower-risk recall
Due to product exhibiting potential to generate either invalid or false negative results.
Contact the company
What happened, in plain English
Hologic recalls the Aptima HPV Assay Kit (model 303585) because it can produce false negative results, meaning it might miss HPV infections. This could lead to incorrect health decisions if used for testing. Read more at govinfonow.com/recall/49964-hologic-aptima-hpv-assay-kit-recall-false-negative-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/49964-hologic-aptima-hpv-assay-kit-recall-false-negative-results-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1586-2026
Cite this page
“Hologic Aptima HPV Assay Kit Recall: False Negative Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49964-hologic-aptima-hpv-assay-kit-recall-false-negative-results-risk. Based on FDA recall #Z-1586-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1586-2026%22&limit=1).
Why it’s dangerous
The kit can generate false negative results, meaning it might show no HPV infection when one is present. This could lead to missed diagnoses and incorrect health decisions. The risk is not immediate but depends on the test's use in clinical settings.
Who’s affected
Healthcare providers and labs using the Aptima HPV Assay Kit (model 303585) are affected. Those testing for HPV infections may be at risk of incorrect results.
How to tell if you have this one
Check for the model number 303585 on the kit. The kit includes a refrigerated box (PN 302883) and a room temperature box (PN 302885). UDI numbers 15420045500051 and 15420045500068 identify the affected kits.
- Brand
Hologic- Category
Medical device
What to do — step by step
Check Kit Details
Verify the model number 303585 and UDI numbers 15420045500051 or 15420045500068 on the kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Iowa, Missouri, New Mexico, North Carolina, Puerto Rico, Tennessee.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1586-2026 (February 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1586-2026 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.