FDA Medical devices recall ·
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel… recall
- Recall number
- Z-1164-2025
- Date
- (initiated January 20, 2025)
- Company / brand
- Microbiologics Inc
200 Cooper Ave N, Saint Cloud, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 27 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33
Distribution
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1164-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.