FDAClass IIFebruary 16, 2022

Gentueri Viral Transport Medium Kit with 8cm Breakpoint recall: Sterility Concern

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Why was Gentueri Viral Transport Medium Kit with 8cm Breakpoint recalled?

Kits failed sterility testing and showed evidence of contamination.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Recalling firm
Gentueri Inc
Quantity
13,975 units (2 mL in a 15 mL conical tube)
Distribution
Domestic: Illinois, Nebraska, and Wisconsin.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls