🔍 RecallPedia

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

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: 10845357043563; Lot Number: HE0065-29
  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 A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
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 SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

Product Codes/Lot Numbers:

UDI-DI: 10845357043563; Lot Number: HE0065-29

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1371-2025

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