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Lower risk Medical device recall · FDA · Published March 18, 2021

Gentueri Viral Transport Medium Recall: Contamination Risk

Gentueri Inc recalls sterile Viral Transport Medium (VTM) due to potential sample contamination from visual turbidity. Affected lots may cause inaccurate test results.

🇺🇸 FDA recall #Z-0504-2022Medical deviceGentuer: Inc ›
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Recalling firmGentueri Inc312 Locust Dr · Verona, WI 53593-2215
✎ GovInfoNow plain-language explainer

What happened, in plain English

Gentueri Inc is recalling sterile Viral Transport Medium (VTM) products that may show discoloration or turbidity, which could contaminate samples during testing. This affects lab users who rely on these products for diagnostic testing. Read more at govinfonow.com/recall/63035-gentueri-viral-transport-medium-recall-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63035-gentueri-viral-transport-medium-recall-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0504-2022

Cite this page

“Gentueri Viral Transport Medium Recall: Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63035-gentueri-viral-transport-medium-recall-contamination-risk. Based on FDA recall #Z-0504-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0504-2022%22&limit=1).

Why it’s dangerous

The medium may develop visible discoloration or turbidity, which could introduce contaminants into samples. This might lead to inaccurate test results if the contaminated medium is used for viral testing.

Who’s affected

Lab technicians and healthcare facilities using Gentueri's sterile Viral Transport Medium for diagnostic testing are most at risk. The recall targets specific production lots.

How to tell if you have this one

Check for the product name 'Gentueri Viral Transport Medium (VTM)', sterile IVD grade, and lot number 1142. The product was sold with catalog number 3300-000.

  • Brand
    Gentuer: Inc
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number and catalog number to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of Indiana.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Mar 18, 202112. FDA classified it Class II: Jan 18, 202223. Published in FDA’s Enforcement Report: Jan 26, 202234. FDA terminated the recall: Aug 28, 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.

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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-0504-2022 (March 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0504-2022 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