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Lower risk Medical device recall · FDA · Published October 23, 2020

Hardy Diagnostics Viral Transport Medium May Contaminate COVID-19 Tests

Hardy Diagnostics recalls Viral Transport Medium tubes due to potential contamination that could compromise COVID-19 test results. Affected lots include specific expiration dates and product codes.

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

🇺🇸 FDA recall #Z-0655-2021Medical deviceHardy Diagnostics ›
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Contact the company

Recalling firmHardy Diagnostics1430 W McCoy Ln · Santa Maria, CA 93455-1005
✎ GovInfoNow plain-language explainer

Hardy Diagnostics is recalling Viral Transport Medium tubes that could become contaminated, potentially leading to inaccurate COVID-19 test results. This affects specific batches sold between 2020 and 2021. Read more at govinfonow.com/recall/64058-hardy-diagnostics-viral-transport-medium-may-contaminate-covid-19-tests.

Source Summary by GovInfoNow · govinfonow.com/recall/64058-hardy-diagnostics-viral-transport-medium-may-contaminate-covid-19-tests · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0655-2021

Cite this page

“Hardy Diagnostics Viral Transport Medium May Contaminate COVID-19 Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64058-hardy-diagnostics-viral-transport-medium-may-contaminate-covid-19-tests. Based on FDA recall #Z-0655-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2021%22&limit=1).

The FDA announced on Oct. 23, 2020, that Hardy Diagnostics is recalling Viral Transport Medium due to potential contamination that may compromise COVID-19 detection. The agency issued recall number Z-0655-2021 for the Class II device.

How to tell if you have it

  • Brand: Hardy Diagnostics
  • Product: Viral Transport Medium, 3ml, Ref: R99
  • Container type: Tube
  • Packaged: 20 tubes/box
  • Lot Numbers: 129507P, 129735P, 129320P, 129932P, 130049P, 460929P, 463439P, 463986P, 459930P, 460805P, 462411P, 459717P, 463483P, 462121P, 460391P, 463782P, 461645P, 461643P, 461289P, 461381P, 460561P, 459718P, 461994P, 462076P, 466688, 459774P, 460618P, 461262P, 461378P, 462375P, 461995P, 460997P, 464517, 460802P, 459830P, 460565P, 460290P, 461013P, 464529, 460621P, 459345P, 460939P, 458991P, 460506P, 460954P, 461362P, 461832P, 462511P, 460433P
  • Units affected: 686,920 devices

The hazard

There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.

Context

GovInfoNow's records show Hardy Diagnostics has 6 other recalls on record since 2019-11-14. Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30: False Susceptibility Results Risk (2026-06-08) and HardyCHROM CRE Culture Media Recall: Klebsiella Pneumoniae Breakthrough Risk (2025-05-06). Other recent recalls of similar products include GET TESTED HPV Antigen Test: Distribution Without Premarket Approval (2025-11-03).

How to tell if you have this one

Check for the product name 'Viral Transport Medium, 3ml, Ref: R99' in plastic tubes. Look for lot numbers like 129507P (expiring 10/28/2020) or 460929P (expiring 11/4/2020) on the packaging.

  • Brand
    Hardy Diagnostics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number and expiration date on the tube packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 40 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Oct 23, 202012. FDA classified it Class II: Dec 21, 202023. Published in FDA’s Enforcement Report: Dec 30, 202034. FDA terminated the recall: Sep 20, 2022420202022
  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.

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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-0655-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0655-2021 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