Summary
The FDA issued a Class II for MPOX Test by GET TESTED INTERNATIONAL AB. Reason: Distribution without premarket approval/clearance..
Details
Source
Device Recall
External ID
Z-0745-2026
Action Date
2025-12-10
Status
Ongoing
Category
device
Product Description
MPOX Test
Lot/Code Info: EAN: 7340221708976; SKU: A-MPVAR; UDI-DI: None; Lot/Serial Number: All Lots;
Quantity Affected: 4 units
Reason for Recall
Distribution without premarket approval/clearance.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-03
Company
Vastervik
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 336 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GET TESTED INTERNATIONAL AB has 92 FDA actions in our database, including 92 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 (GET TESTED INTERNATIONAL AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GET TESTED INTERNATIONAL AB have FDA actions?
GET TESTED INTERNATIONAL AB has 92 FDA actions in our database, including 92 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0745-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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