Microbiologics recalls HPV verification panels with low HPV 16 L1 concentration that may cause invalid test results. Affected lots 8235-32 and 8235-33 should be checked for invalid results.
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.
Microbiologics is recalling HPV verification panels that may produce invalid results due to low HPV 16 L1 concentration. This could lead to incorrect test outcomes if used without proper quality control.
The panels were released without proper quality control, causing the HPV 16 L1 concentration to be too low. This can lead to QC failures, no detection, or invalid results on some testing instruments.
Users of the HPV verification panels with lot numbers 8235-32 and 8235-33 are affected. Healthcare providers and labs using these specific lots may be at risk of invalid test results.
Check for lot numbers 8235-32 or 8235-33 on the HPV verification panels. The product is an in-vitro diagnostic test with UDI/DI 70845357043077.
If you have the affected lot numbers, verify test results for invalid outcomes.
Lot numbers 8235-32 and 8235-33 of the Microbiologics Multi-Strain HPV Verification Panel (Inactivated Pellet).
Internal quality control procedures were not followed correctly, leading to panels with low HPV 16 L1 concentration that may cause invalid test results.
Check if your test results are invalid; if so, contact your lab or healthcare provider for retesting.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-1164-2025 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-1164-2025 from Microbiologics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
