Skip to content
Get alerts
GovInfoNow
Unrated Medical device recall · FDA · Published July 27, 2022

Microbiologics Helix Elite Inactivated Standard: Not UK-Registered Product

Microbiologics recalls Helix Elite Inactivated Standard (HE0071N/HE0073N) due to not being registered for UK use. Consumers should check labels for UDI numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1740-2022Medical deviceMicrobiologics ›
Take action

Contact the company

Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling its Helix Elite Inactivated Standard COVID-19 test kits because they were not registered for use in the UK. This means the products may not meet UK safety standards and could pose risks if used there. Read more at govinfonow.com/recall/60301-microbiologics-helix-elite-inactivated-standard-not-uk-registered-product.

Source Summary by GovInfoNow · govinfonow.com/recall/60301-microbiologics-helix-elite-inactivated-standard-not-uk-registered-product · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1740-2022

Cite this page

“Microbiologics Helix Elite Inactivated Standard: Not UK-Registered Product.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60301-microbiologics-helix-elite-inactivated-standard-not-uk-registered-product. Based on FDA recall #Z-1740-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1740-2022%22&limit=1).

The FDA announced on July 27, 2022, that Microbiologics Inc. is recalling Helix Elite Inactivated Standard products because they are not registered for use in the United Kingdom. The recall affects two units distributed internationally.

How to tell if you have it

  • Brand: Microbiologics
  • Product: Helix Elite Inactivated Standard
  • Item a: Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N, UDI 10845357043846, Lot HE0071-01-1, Exp 12/31/2022
  • Item b: Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N, UDI 10845357043945, Lot HE0073-02-2, Exp 02/28/2023

The hazard

The products are not registered for use in the United Kingdom. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Microbiologics Inc has issued 35 other recalls since June 6, 2017. Recent brand recalls include the Dec. 2, 2025 KWIK-STIK 6-Pack Recall for microorganism recovery failure and the Nov. 13, 2025 KWIK-STIK Quality Control Kit Recall for lot labeling mix-ups. Other recent recalls of similar products include the Nov. 3, 2025 GET TESTED International AB GI Microbiome Profile Small recall and the Nov. 3, 2025 Syphilis Test recall due to unapproved distribution.

How to tell if you have this one

Check the label for UDI numbers: 10845357043846 (HE0071N) or 10845357043945 (HE0073N). Also look for expiration dates: 12/31/2022 or 02/28/2023.

  • Brand
    Microbiologics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Label

    Look for UDI numbers 10845357043846 or 10845357043945 on the product label.

How this recall unfolded

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Jul 27, 202212. FDA classified it Class III: Sep 16, 202223. Published in FDA’s Enforcement Report: Sep 21, 202234. FDA terminated the recall: Aug 2, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

SD Biosensor STANDARD Q COVID-19 Ag Home Test Not Approved for U.S. Use
SD BiosensorSafeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.

Latest medical device recalls

Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS
Tandem Diabetes Care · July 16, 2026BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1740-2022 (July 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1740-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA