Recall Z-1164-2025— Microbiologics Inc
Class II · Ongoing
Class II FDA medical device recall by Microbiologics Inc, initiated 2025-01-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test. Reason: 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-20
- Firm location
- Saint Cloud, MN, United States
Product description
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.