# FDA recall Z-1163-2025

> **Microbiologics Inc** · Class II · device recall initiated 2025-01-20.

## Product

Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test

## Reason for recall

Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

## Distribution

Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.

## Key facts

- **Recall number:** Z-1163-2025
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-20
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1163-2025

## Citation

> AI Analytics. FDA recall Z-1163-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1163-2025. Source: US FDA. Licensed CC0.

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