CLASS III Device recall · Reported 21 Sep 2022 · FDA Enforcement Report

Helix Elite Inactivated Standard, labeled as recalled by Microbiologics

Microbiologics is recalling Helix Elite Inactivated Standard, labeled as: a. Inactivated Sars-CoV-2 B.1.1.7 Whole. The recall was initiated on 27 Jul 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.
Quantity recalled2

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-1740-2022
FDA event ID
90761
Recalling firm
Microbiologics, Saint Cloud, MN
Classification
Class III
Status
Terminated
Recall initiated
27 Jul 2022
FDA classified
16 Sep 2022
Reported
21 Sep 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

27 Jul 2022Recall initiated by company
16 Sep 2022Classified by FDA+51 days
21 Sep 2022Published in enforcement report+5 days

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

Reason for recall

Product not registered for use in the UK

Product as listed by the FDA

Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

Where it was distributed

International distribution to the country of United Kingdom.

Questions about this recall

Why was it recalled?

Product not registered for use in the UK

Which lots are affected?

a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.

Where was it sold?

International distribution to the country of United Kingdom.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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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