E25Bio, Inc. Recall 89485
Description: E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
E25Bio, Inc. Recall 89485 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0564-2022 |
| Event ID | 89485 |
| Event Description | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of MA, FL, and HI. |
| Quantity | 73,300 units |
| Recall Reason | The 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 Classification | 20220216 |
| Device Code Info | Lot 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 Date | 20220209 |
| Recall Initiation Date | 20220127 |
| Recalling Firm | E25Bio, Inc. |
| Initial Notification | Letter |
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