Lower riskMedical device recall · FDA · Published January 20, 2025
Microbiologics HPV Control Panel Recall: Low HPV 16 L1 Concentration Causes Invalid Test
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.
Take action
Contact the company
📍Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
“Microbiologics HPV Control Panel Recall: Low HPV 16 L1 Concentration Causes Invalid Test.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53059-microbiologics-hpv-control-panel-recall-low-hpv-16-l1-concentration. Based on FDA recall #Z-1163-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1163-2025%22&limit=1).
The FDA announced on Jan. 20, 2025, that Microbiologics Inc is recalling its Multi-Strain Human Papillomavirus (HPV) Control Panel due to internal quality control failures. The hazard involves potential invalid results or no detection of HPV 16 L1 in some instruments and assays.
How to tell if you have it
Brand: Microbiologics
Product: Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro
UDI/DI: 70845357043077
Lot Number: 8234-22
Quantity: 16 units
The hazard
Internal quality control procedures were not followed correctly for the testing and release of three lots of REF 8234/8235, resulting in the release of products that should have failed. 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.
Context
GovInfoNow's records show Microbiologics Inc has had 35 other recalls since June 6, 2017. Recent brand recalls include a Dec. 2, 2025 LYFO DISK recall for failed microorganism recovery and a Nov. 13, 2025 KWIK-STIK Quality Control Kit recall for lot labeling mix-ups. Other recent recalls of similar products include the Feb. 18, 2026 Hologic Aptima HPV Assay Kit recall for false negative results risk and the June 26, 2026 Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit recall for incorrect algorithms.
How to tell if you have this one
Check for lot number 8234-22 on the HPV control panel packaging. The product is an in-vitro diagnostic test used for HPV detection.
Brand
Microbiolog: a short, human brand name for headings (e.g. "Trsmima")
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
Recall number
Product, codes & lots
Quantity
Z-1163-2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test; UDI/DI 70845357043077, Lot Number 8234-22
16 units
Z-1164-2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test; UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33
27 units
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot number 8234-22 on the packaging of the HPV control panel.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1163-2025 (January 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1163-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.