Lower riskMedical device recall · FDA · Published July 6, 2020
Gentueri Viral Transport Kit Recall: Contamination Risk
Gentueri Inc recalls Viral Transport Medium Kits with 8cm Breakpoint Swab due to sterility testing failures and contamination evidence. Affected kits may pose infection risks.
“Gentueri Viral Transport Kit Recall: Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64754-gentueri-viral-transport-kit-recall-contamination-risk. Based on FDA recall #Z-0561-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2022%22&limit=1).
Gentueri Inc recalled its Viral Transport Medium Kit with 8cm Breakpoint Swab due to contamination risks, according to the FDA on July 6, 2020. The voluntary Class II recall involved 13,975 units distributed in Illinois, Nebraska, and Wisconsin.
How to tell if you have it
Brand: Gentueri Inc
Product: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
CAT#: 3300-000
Lot No.: 1029
Quantity: 13,975 units
The hazard
The kits failed sterility testing and showed evidence of contamination, according to the FDA. The record does not report specific incidents or injuries associated with this recall.
Context
GovInfoNow's records show Gentueri Inc has one other recall on record since March 18, 2021, involving a Viral Transport Medium Recall for contamination risk on that date. Other recent recalls of similar products include Boston Scientific EndoVive Safety PEG Kit Recall (Feb. 10, 2026), AVID Medical Halyard Transport Bag Kit Recall (Jan. 2, 2026), and Medline Convenience Kits Recall (Jan. 7, 2026).
How to tell if you have this one
Check for the kit name 'Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab' and the lot number 1029. The kit has a catalog number of 3300-000.
Brand
Gentuer: Inc
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Identify the kit by its catalog number 3300-000 and lot number 1029.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: Illinois, Nebraska, and Wisconsin.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Nebraska, Wisconsin.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0561-2022 (July 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0561-2022 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.