Summary
The FDA issued a Class II for Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab by Gentueri Inc. Reason: Kits failed sterility testing and showed evidence of contamination..
Details
Source
Device Recall
External ID
Z-0561-2022
Action Date
2022-02-16
Status
Terminated
Category
device
Product Description
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Lot/Code Info: CAT#: 3300-000; Lot No.: 1029.
Quantity Affected: 13,975 units (2 mL in a 15 mL conical tube)
Reason for Recall
Kits failed sterility testing and showed evidence of contamination.
Distribution
Domestic: Illinois, Nebraska, and Wisconsin.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-07-06
Company
Verona, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Gentueri Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gentueri Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gentueri Inc have FDA actions?
Gentueri Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0561-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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