CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
Helix Elite" Inactivated Standard recalled by Microbiologics
Microbiologics is recalling Helix Elite" Inactivated Standard: Inactivated Sars-CoV-2 Whole Virus (Pellet), distributed nationwide in the US. The recall was initiated on 20 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1371-2025
- FDA event ID
- 96382
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2025
- FDA classified
- 14 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Feb 2025 | Recall initiated by company | |
| 14 Mar 2025 | Classified by FDA | +22 days |
| 26 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Where it was distributed
US Nationwide distribution in the states of TX. UK.
Questions about this recall
Why was it recalled?
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Which lots are affected?
UDI-DI: 10845357043563; Lot Number: HE0065-29
Where was it sold?
US Nationwide distribution in the states of TX. UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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