---
title: "Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1... — FDA record Z-1740-2022 | Is It on Recall"
description: "Product not registered for use in the UK"
url: https://isitonrecall.com/recall/fda-device-z-1740-2022-helix-elite-inactivated-standard-labeled-as-a-inactivated-sars-cov-2-b-1-1-7-whole-virus-ref-he0071n/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactiva... — FDA record Z-1740-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **Reason**: Product not registered for use in the UK
- **Classification**: Class III
- **Recalling firm**: Microbiologics Inc
- **Quantity**: 2
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1740-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1740-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution to the country of United Kingdom.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 21, 2022
- **Recall initiation date**: Jul 27, 2022
- **Center classification date**: Sep 16, 2022
- **Termination date**: Aug 2, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1740-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Microbiologics Inc records](https://isitonrecall.com/brand/microbiologics-inc/)