Z-1740-2022Class III

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

Name: Z-1740-2022 Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b...
Creator: Microbiologics Inc
Published: 2022-07-27
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2022-07-27 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of 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... on 2022-07-27. FDA classified it as Class III and gives the reason as "Product not registered for use in the UK". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1740-2022
Classification: Class III
Status: Terminated
Initiated: 2022-07-27
Posted: 2022-09-14
Terminated: 2024-08-02
Recalling firm: Microbiologics, Inc.
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
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: Product not registered for use in the UK
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Microbiologics initially contacted the consignee via email on 07/27/2022. A formal letter was provided via email on 08/15/2022. The notification instructed the consignee to review lab procedures to understand how the recall affects their usage, discard any units depending on the lab procedures, complete and return the response form, maintain the recall letter for record, and contact Microbiologics for replacement if needed.
Quantity in commerce: 2
Distribution: International distribution to the country of United Kingdom.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1740-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2022	Class III	Terminated	Voluntary: Firm initiated	2022-09-21	2022-09-16

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)