E25Bio, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0564-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: January 27, 2022

Date Posted: February 16, 2022

Recall Number: Z-0564-2022

Event ID: 89485

Reason for Recall:

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.

Status: Terminated

Product Quantity: 73,300 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated