FDA Medical devices recall ·
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus… recall
- Recall number
- Z-1371-2025
- Date
- (initiated February 20, 2025)
- Company / brand
- Microbiologics Inc
200 Cooper Ave N, Saint Cloud, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Why was it recalled?
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10845357043563; Lot Number: HE0065-29
Distribution
US Nationwide distribution in the states of TX. UK.
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1371-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.