Microbiologics recalls HPV control panels with lot 8234-22 due to low HPV 16 L:1 concentration causing invalid test results. Affected users should contact for guidance.
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 control panels that may produce invalid test results because the HPV 16 L1 concentration was too low during manufacturing. This could lead to inaccurate test outcomes for HPV detection.
The control panels were manufactured with a low concentration of HPV 16 L1, which can cause some instruments to fail or produce invalid results. This means the test results might not be accurate for detecting HPV.
Users of HPV control panels with lot number 8234-22 are affected. Laboratory personnel and clinics using these panels for HPV testing are most at risk.
Check for lot number 8234-22 on the HPV control panel packaging. The product is an in-vitro diagnostic test used for HPV detection.
Look for lot number 8234-22 on the packaging of the HPV control panel.
The recall is due to internal quality control issues that caused the HPV 16 L1 concentration to be too low, potentially leading to invalid test results.
Check the lot number on the packaging. If it's 8234-22, contact Microbiologics for guidance on next steps.
This product is not dangerous to use but may produce invalid test results if the HPV 16 L1 concentration is too low.
We’ve drafted a message you can send Microbiolog: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-1163-2025 — Microbiolog: a short, human brand name for headings (e.g. "Trsmima") Microbiolog: a short, human br Hello, I own a Microbiolog: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-1163-2025 from Microbiolog: a short, human brand name for headings (e.g. "Trsmima"). 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.
