Helix Elite Inactivated Standard (Microbiologics) – UK Registration (2022)
False positive results may lead to inappropriate medical treatment or unnecessary side effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Microbiologics Inc is recalling Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF H due to Product not registered for use in the UK. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product not registered for use in the UK
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026