CLASS II Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

Viral Transport Medium Kit with Breakpoint Swab recalled by Gentueri

Gentueri is recalling Gentueri Viral Transport Medium Kit with Breakpoint Swab, distributed in Illinois, Nebraska, Wisconsin. The recall was initiated on 6 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCAT#: 3300-000; Lot No.: 1029.

Quantity recalled13,975 units (2 mL in a 15 mL conical tube)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0561-2022
FDA event ID: 89336
Recalling firm: Gentueri, Verona, WI
Classification: Class II
Status: Terminated
Recall initiated: 6 Jul 2020
FDA classified: 4 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

6 Jul 2020	Recall initiated by company
4 Feb 2022	Classified by FDA	+578 days
16 Feb 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Kits failed sterility testing and showed evidence of contamination.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Where it was distributed

Domestic: Illinois, Nebraska, and Wisconsin.

Illinois Nebraska Wisconsin

Questions about this recall

Is Viral Transport Medium Kit with Breakpoint Swab recalled?

Yes. Gentueri recalled Viral Transport Medium Kit with Breakpoint Swab on 6 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-0561-2022.

Why was it recalled?

Kits failed sterility testing and showed evidence of contamination.

Which lots are affected?

CAT#: 3300-000; Lot No.: 1029.

Where was it sold?

Domestic: Illinois, Nebraska, and Wisconsin.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Gentueri

All 2

Reported	Class	Recall	Company	Reason	Where
26 Jan 2022Device	CLASS II	Viral Transport Medium (VTM), Sterile, IVD recalled by Gentueri	Gentueri	Sterility	Nationwide

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