CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
Multi-Strain Human Papillomavirus (HPV) Verification Panel recalled
Microbiologics is recalling Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), distributed nationwide in the US. The recall was initiated on 20 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1164-2025
- FDA event ID
- 96166
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jan 2025
- FDA classified
- 12 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jan 2025 | Recall initiated by company | |
| 12 Feb 2025 | Classified by FDA | +23 days |
| 19 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96166This product is part of a recall event; the main page for the event is Multi-Strain Human Papillomavirus (HPV) Control Panel recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Multi-Strain Human Papillomavirus (HPV) Control Panel recalled | Microbiologics | Potency & Assay | Nationwide |
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