CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Helix Elite Inactivated Standard recalled by Microbiologics

Microbiologics is recalling Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial, 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

Lot, batch or date codesUDI-DI: 10845357042184; Lot Number: HE0044-131

Quantity recalled28 units

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-1454-2025
FDA event ID: 96381
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Ongoing
Recall initiated: 20 Feb 2025
FDA classified: 25 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: CPAP & Ventilators

Timeline

20 Feb 2025	Recall initiated by company
25 Mar 2025	Classified by FDA	+33 days
2 Apr 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The RSV target may give a late Ct value and could potentially not pass QC.

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 Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

Where it was distributed

Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.

Nationwide Kentucky Montana New Jersey New York Wisconsin

Stores named: Target

Questions about this recall

Is Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial recalled?

Yes. Microbiologics recalled Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial on 20 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1454-2025.

Why was it recalled?

The RSV target may give a late Ct value and could potentially not pass QC.

Which lots are affected?

UDI-DI: 10845357042184; Lot Number: HE0044-131

Where was it sold?

Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, 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 21 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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