🔍 RecallPedia

Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test

Class I - Dangerous
🏥 Medical Devices Recalled: January 20, 2025 Microbiologics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 70845357043077, Lot Number 8234-22
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Microbiologics Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test

Product Codes/Lot Numbers:

UDI/DI 70845357043077, Lot Number 8234-22

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1163-2025

Related Recalls