Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.