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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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