# FDA recall Z-1586-2026

> **Hologic, Inc.** · Class II · device recall initiated 2026-02-18.

## Product

Brand Name: Aptima HPV Assay  Product Name: Aptima HPV Assay  Model/Catalog Number: 303585  Product Description: Aptima HPV assay  Component: No

## Reason for recall

Due to product exhibiting potential to generate either invalid or false negative results.

## Distribution

U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.

## Key facts

- **Recall number:** Z-1586-2026
- **Recalling firm:** Hologic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-18
- **Report date:** 2026-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1586-2026

## Citation

> AI Analytics. FDA recall Z-1586-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1586-2026. Source: US FDA. Licensed CC0.

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