CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
Viral Transport Medium (VTM), Sterile, IVD recalled by Gentueri
Gentueri is recalling Viral Transport Medium (VTM), Sterile, IVD, distributed nationwide in the US. The recall was initiated on 18 Mar 2021 and the FDA has classified it as Class II.
Check your package
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-0504-2022
- FDA event ID
- 89337
- Recalling firm
- Gentueri, Verona, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2021
- FDA classified
- 18 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Mar 2021 | Recall initiated by company | |
| 18 Jan 2022 | Classified by FDA | +306 days |
| 26 Jan 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Product as listed by the FDA
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Where it was distributed
US Nationwide distribution in the state of Indiana.
Questions about this recall
Why was it recalled?
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Which lots are affected?
CAT #: 3300-000; Lot #: 1142
Where was it sold?
US Nationwide distribution in the state of Indiana.
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 26 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Viral Transport Medium Kit with Breakpoint Swab recalled by Gentueri | Gentueri | Sterility | IL, NE, WI |
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