Product Safety Recalls

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USA Medical, LLC Recall 90098

Description: Diagnostic Kit SARS-cCo V Antigen Rapid Test

USA Medical, LLC Recall 90098 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1050-2022
Event ID90098
Event DescriptionDiagnostic Kit SARS-cCo V Antigen Rapid Test
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Quantity2055 kits
Recall ReasonCOVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Device Classification20220518
Device Code InfoCatalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
Center Classification Date20220506
Recall Initiation Date20220404
Recalling FirmUSA Medical, LLC
Initial Notification Letter
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