FDA-Device2025-02-19Class II
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Microbiologics Inc
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
Affected count
27 units
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2025Don't want to check this manually?
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