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Empowered Diagnostics LLC Recall 89315

Description: CovClear COVID-19 Rapid Antigen Test, ATG 900-031

Empowered Diagnostics LLC Recall 89315 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0480-2022
Event ID89315
Event DescriptionCovClear COVID-19 Rapid Antigen Test, ATG 900-031
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity284,575 units
Recall ReasonCOVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Device Classification20220209
Device Code InfoAll lots
Center Classification Date20220128
Recall Initiation Date20211222
Recalling FirmEmpowered Diagnostics LLC
Initial Notification E-Mail
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