Device product
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Z-0564-2022
Product summary
- Firm
- E25Bio, Inc.
- Event
- Event 89485
- Status
- Terminated
- Classification
- Class I
- Quantity
- 73,300 units
- Official record key
device-enforcement:Z-0564-2022
Official wording
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.
Code information: 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
Distribution pattern: US Nationwide distribution in the states of MA, FL, and HI.
Derived failure modes
-
Unknown
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.