Z-1371-2025Class II

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed...

Name: Z-1371-2025 Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed...
Creator: Microbiologics Inc
Published: 2025-02-20
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-02-20 / Open, Classified / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N on 2025-02-20. FDA classified it as Class II and gives the reason as "The A549 human cell target (human cells for sample adequacy control) may give a late Ct value". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1371-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-20
Posted: 2025-03-14
Recalling firm: Microbiologics, Inc.
Product: Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Medical Device Recall notification letter dated 2/20/25 was sent to customers. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected] 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns. Collect calls may be made.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution in the states of TX. UK.
Product codes and lots: UDI-DI: 10845357043563; Lot Number: HE0065-29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1371-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14

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)