Microbiologics Inc: Device Recall
Recall #Z-1164-2025 · 01/20/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1164-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Microbiologics Inc
- Status
- Ongoing
- Date Initiated
- 01/20/2025
- Location
- Saint Cloud, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
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.
Product Description
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
Other Recalls by Microbiologics Inc
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 11/13/2025
- Class II: Risk 06/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.