Microbiologics Multi-Strain Human Papillomavirus — Class II medical device recall Z-1163-2025
Ongoing recall by Microbiologics Inc, reported 2025-02-19, distributed nationwide. Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/
| Recall number | Z-1163-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2025-01-20 |
| Classified | 2025-02-12 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, FR, GB, NL, NZ, SE |
| Quantity | 16 units |
| UPC / GTIN / UDI-DI | 70845357043077 |
| Lot numbers | 8234-22 |
| Model numbers | 8234 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1163-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.