Reported Sep 21, 2022 · Terminated

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

Microbiologics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440

Is this the product you have?

  • Helix Elite Inactivated Standard
  • labeled asa. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Lot codes and dates
  • a
  • UDI Number10845357043846
  • Lot NumberHE0071-01-1
  • Expiration Date12/31/2022. b
  • UDI Number10845357043945
  • Lot NumberHE0073-02-2
  • Expiration Date02/28/2023
Amount recalled
2

Why it was recalled

Product not registered for use in the UK

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 2, 2024 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.