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Migo Trading LLC Recall 89028

Description: FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

Migo Trading LLC Recall 89028 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0421-2022
Event ID89028
Event DescriptionFLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Product TypeDevices
Quantity200,100 units
Recall ReasonDevices 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.
Device Classification20220105
Device Code InfoUDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023
Center Classification Date20211227
Recall Initiation Date20211104
Recalling FirmMigo Trading LLC
Initial Notification Letter
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