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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Microbiologics HPV Control and Verification Panels Recalled for Test Failures

Agency Publication Date: February 12, 2025
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Summary

Microbiologics Inc. has recalled three lots of its Multi-Strain Human Papillomavirus (HPV) Control and Verification Panels, affecting approximately 43 units. The recall was initiated because internal quality control procedures were not followed, leading to the release of panels with low concentrations of the HPV 16 L1 target. These panels may cause invalid results or fail to detect HPV on certain laboratory instruments. No injuries or incorrect diagnoses have been reported to date.

Risk

The low concentration of the test target can cause laboratory quality control failures or invalid results. This could lead to testing delays or incorrect diagnostic reports, potentially affecting patient treatment decisions for HPV.

What You Should Do

  1. This recall affects the Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (REF 8234) and Verification Panel (REF 8235) in inactivated pellet form.
  2. Identify recalled items by checking for UDI/DI 70845357043077 and Lot Number 8234-22 on the Control Panel packaging, or Lot Numbers 8235-32 and 8235-33 on the Verification Panel packaging.
  3. Stop using the recalled product immediately to prevent invalid diagnostic test results.
  4. Contact Microbiologics Inc. or your laboratory's product distributor to arrange for a return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
Model / REF:
REF 8234
Lot Numbers:
8234-22
UDI:
70845357043077

Quantity: 16 units; Recall #: Z-1163-2025

Product: Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)
Model / REF:
REF 8235
Lot Numbers:
8235-32
8235-33
UDI:
70845357043077

Quantity: 27 units; Recall #: Z-1164-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96166
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Microbiologics Inc; Direct distribution to laboratories
Manufactured In: United States
Units Affected: 2 products (16 units; 27 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.