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Lower risk Medical device recall · FDA · Published March 2, 2021

Azure Biotech Recalls COVID-19 Rapid Test Devices Due to Incorrect Labeling and Expiration

Azure Biotech recalls specific COVID-19 IgG/IgM Rapid Test Devices with incorrect labeling and unsupported 24-month expiration dating. Affected units may not be reliable for diagnostic use.

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

🇺🇸 FDA recall #Z-1432-2021Medical deviceAzure Biotech ›
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Contact the company

Recalling firmAZURE BIOTECH INC5250 Gulfton St Ste 2c · Houston, TX 77081-2936
✎ GovInfoNow plain-language explainer

Azure Biotech is recalling certain COVID-19 rapid test devices because they have incorrect labeling and an unsupported 24-month expiration date. This could mean the tests are not reliable for diagnostic use as intended. Read more at govinfonow.com/recall/63177-azure-biotech-recalls-covid-19-rapid-test-devices-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/63177-azure-biotech-recalls-covid-19-rapid-test-devices-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1432-2021

Cite this page

“Azure Biotech Recalls COVID-19 Rapid Test Devices Due to Incorrect Labeling and Expiration.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63177-azure-biotech-recalls-covid-19-rapid-test-devices-due-to. Based on FDA recall #Z-1432-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1432-2021%22&limit=1).

The FDA announced on March 2, 2021, that Azure Biotech is recalling Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect labeling and unsupported expiration dating. The recall affects approximately 100,000 kits distributed in the U.S., Canada, and worldwide.

How to tell if you have it

  • Brand: Azure Biotech
  • Product: Assure COVID-19 IgG/IgM Rapid Test Device
  • Pouch Label variants: FaStep Rapid Diagnostic Test * Rapid Reliable Simple * COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) * For Emergency Use Authorization Only; ECOTEST RAPID DIAGNOSTIC TEST * /Rapid / Reliable / Simple/ * COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) * For Emergency Use Authorization Only
  • Box Label variants: FaStep Rapid Diagnostic Test * COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) * For Emergency Use Authorization Only * For in vitro diagnostic use only; ECOTEST RAPID DIAGNOSTIC TEST * Rapid Reliable Simple * COVID-19 IgG/IgM Rapid Test Device * For Professional in vitro diagnostic use only * For Emergency Use Authorization Only
  • Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030
  • Quantity: 100,000 kits
  • Distribution: U.S. (CA, FL, GA, IL, LA, MD, MN, NC, TX, UT, VA, WA), Canada, Worldwide

The hazard

The devices carry incorrect labeling stating they are "for diagnostic use" and feature an unsupported 24-month expiration date. The FDA said this mislabeling could lead to improper use of the tests.

Context

GovInfoNow's records show Azure Biotech has had prior regulatory issues, including the GET TESTED Biological Age Test distribution without premarket approval on November 3, 2025. Other recent recalls of similar diagnostic products include the Siemens Healthcare Syva EMIT 2000 Quinidine Assay (July 13, 2026) and the Covidien EndoFLIP System (May 13, 2026).

How to tell if you have this one

Check the product label for lot numbers: I2004001, I2004003, I2006128, I2005023, or I2006030. The devices include either 'FaStep Rapid Diagnostic Test' or 'ECOTEST RAPID DIAGNOSTIC TEST' labels.

  • Brand
    Azure Biotech
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for lot numbers I2004001, I2004003, I2006128, I2005023, or I2006030 on the device label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, North Carolina, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Mar 2, 202112. FDA classified it Class II: Apr 16, 202123. Published in FDA’s Enforcement Report: Apr 28, 202134. FDA terminated the recall: Mar 31, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks from using these products?

The recall is due to potential unreliable results, not physical safety risks. There is no immediate danger to health.

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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-1432-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1432-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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