Recall Z-1164-2025 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
| Date | Feb 12, 2025 (initiated Jan 20, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Microbiologics issued and Urgent Medical Device Recall notice to its consignees on 01/20/2025 via email. The notice explained the issue and requested the following actions be taken: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed |
| Quantity | 27 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.