FDAFDA · Food and drugs·Recall number Z-1163-2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Published February 19, 2025 · Recall initiated: January 20, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
- Lot
- UDI/DI 70845357043077, Lot Number 8234-22
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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