CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report

Helix Elite" Molecular Standards: Inactivated Standard recalled

Microbiologics is recalling Helix Elite" Molecular Standards: Inactivated Standard, distributed nationwide in the US. The recall was initiated on 6 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023

Quantity recalled1 unit

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-0699-2022
FDA event ID: 89446
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2017
FDA classified: 1 Mar 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: CPAP & Ventilators

Timeline

6 Jun 2017	Recall initiated by company
1 Mar 2022	Classified by FDA	+1729 days
9 Mar 2022	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

Real-time shelf life testing failed at 24 months

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" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.

Nationwide Alaska California District of Columbia Florida Iowa Idaho Kansas Louisiana Maryland Minnesota Missouri Nebraska New Hampshire New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas

Stores named: Target

Questions about this recall

Why was it recalled?

Real-time shelf life testing failed at 24 months

Which lots are affected?

Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023

Where was it sold?

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.

Other products in this recall event

4 other products · FDA event 89446

This product is part of a recall event; the main page for the event is QC Sets and Panels: Helix Elite recalled by Microbiologics.

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022	CLASS II	QC Sets and Panels: Helix Elite recalled by Microbiologics	Microbiologics	E. coli	Nationwide
9 Mar 2022	CLASS II	Helix Elite" Molecular Standards: Inactivated Standard recalled	Microbiologics	Other	Nationwide
9 Mar 2022	CLASS II	QC Sets and Panels recalled by Microbiologics	Microbiologics	Other	Nationwide
9 Mar 2022	CLASS II	Helix Elite" Molecular Standards: Inactivated Standard recalled	Microbiologics	Other	Nationwide

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