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U.S. Department of Health and Human Services

Class 2 Device Recall FLOWFLEX SARSCOV2 Antigen Rapid Test

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 Class 2 Device Recall FLOWFLEX SARSCOV2 Antigen Rapid Testsee related information
Date Initiated by FirmNovember 04, 2021
Create DateDecember 27, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0421-2022
Recall Event ID 89028
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductFLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Code Information UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023
Recalling Firm/
Manufacturer		 Migo Trading LLC
831 Laca St
Dayton NV 89403-6394
For Additional Information ContactMichael Gothelf
973-810-7444
Manufacturer 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.
FDA Determined
Cause 2		No Marketing Application
ActionOn November 4, 2021, Migo Trading issued URGENT MEDICAL DEVICE RECALL notices and response forms dated November 1, 2021 to customers via email. Actions to be taken by the Customer/User: - Please inspect stock and quarantine impacted product. - Please discard any available inventory in your possession or by your customer s possession. - If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect. It is recommended that you obtain a confirmatory test to determine your SARS-CoV-2 infection status. - Complete and return the attached response form via email at info@migotrading.com
Quantity in Commerce200,100 units
DistributionNY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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