Medical Device Recall: Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Microbiologics Inc · January 20, 2025
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
States Affected
NATIONWIDE
Quantity Affected
16 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1163-2025
Status: ongoing
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