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E25Bio, Inc. Recall 89485

Description: E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

E25Bio, Inc. Recall 89485 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0564-2022
Event ID89485
Event DescriptionE25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Product TypeDevices
DistributionUS Nationwide distribution in the states of MA, FL, and HI.
Quantity73,300 units
Recall ReasonThe Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Device Classification20220216
Device Code InfoLot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020
Center Classification Date20220209
Recall Initiation Date20220127
Recalling FirmE25Bio, Inc.
Initial Notification Letter
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