The Recall Desk
ModerateFDA (Devices)·Z-1371-2025·Announced 2025-03-26

Helix Elite SARS-CoV-2 QC Material Recall Due to Potential Ct Value Issues

Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall of a laboratory quality control material with potential performance issues. No illnesses or injuries have been reported. The hazard is theoretical—a risk that test validity could be compromised if the control material performs incorrectly.

Plain-English summary

Microbiologics Inc is recalling Helix Elite Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet) quality control material, Catalog Number HE0065N, Lot HE0065-29.

The A549 human cell target used in this quality control material for sample adequacy control may produce late Ct (cycle threshold) values. A late Ct value could indicate reduced sensitivity in quality control procedures and may compromise the validity of test results using this control material.

This product has been distributed nationwide in the United States, including Texas, and to the United Kingdom. The recall affects 6 units of this control material.

Laboratories using this product should contact Microbiologics Inc for information about replacement or remediation of any affected quality control procedures and testing.

The recalled product

Product
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Manufacturer
Microbiologics Inc
Category
Medical Device — Quality Control Material
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Microbiologics Inc

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