🔍 RecallPedia

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

Class I - Dangerous
🏥 Medical Devices Recalled: February 20, 2025 Microbiologics Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10845357042184; Lot Number: HE0044-131
  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:
The RSV target may give a late Ct value and could potentially not pass QC.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

Product Codes/Lot Numbers:

UDI-DI: 10845357042184; Lot Number: HE0044-131

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1454-2025

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