Summary
The FDA issued a Class II for FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test by Migo Trading LLC. Reason: Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use a.
Details
Source
Device Recall
External ID
Z-0421-2022
Action Date
2022-01-05
Status
Ongoing
Category
device
Product Description
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Lot/Code Info: UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023
Quantity Affected: 200,100 units
Reason for Recall
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Distribution
NY
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-04
Company
Dayton, NV
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 90 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Migo Trading LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Migo Trading LLC have FDA actions?
This is the only FDA action we have on record for Migo Trading LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0421-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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